Building Trust and Enhancing Brand Reputation in Pharma

Introduction

The pharmaceutical industry has long battled a perception of prioritizing profits over patient well-being. Critics point to the high costs of drugs, aggressive marketing tactics, and a lack of transparency surrounding clinical trials. However, in an era where consumer trust is paramount, pharma companies can no longer afford to disregard these concerns. Trust and a strong brand reputation are essential for success in this highly regulated and scrutinized industry.

A trustworthy brand image fosters patient loyalty, facilitates smoother regulatory approvals, and drives sales growth. In contrast, a tarnished reputation can have severe consequences, from consumer backlash to legal troubles and diminished market share. As such, pharmaceutical companies must adopt strategies that enhance their credibility and position them as ethical, patient-centric organizations.

The Pillars of Trustworthy Pharma Brands

• Transparency and Open Communication: Transparency is a cornerstone of building trust in the pharmaceutical industry. Patients and healthcare professionals demand comprehensive information about products, clinical trials, and potential side effects. A proactive communication and information-sharing culture can go a long way in dispelling doubts and fostering confidence in a brand.

Effective strategies for promoting transparency include:

1. Providing easily accessible and understandable product information on websites, packaging, and marketing materials.

2. Publishing detailed clinical trial data and being upfront about potential risks and limitations.

3. Engaging with patients and advocacy groups through social media, forums, and educational initiatives.

4. Promptly addressing safety concerns or adverse event reports with transparency and accountability.

By embracing open communication, pharmaceutical companies can demonstrate their commitment to patient well-being and establish themselves as reliable sources of information.

• Putting Patients First: In an industry that directly impacts human health, pharmaceutical companies must prioritize patient needs above all else. A patient-centric approach to drug development, marketing, and support services can go a long way in building trust and fostering a positive brand reputation.

Strategies to prioritize patient needs include:

1. Involving patient advocacy groups and incorporating patient feedback throughout the drug development.

2. Developing user-friendly medication packaging, instructions, and support resources tailored to diverse patient populations.

3. Investing in patient assistance programs to improve access to essential medications for those in need.

4. Training sales and marketing teams to prioritize patient education and support over aggressive promotion.

Pharmaceutical companies can position themselves as trustworthy partners in healthcare by consistently demonstrating a commitment to improving patient outcomes and quality of life.

• Commitment to Ethics and Compliance: Ethical practices and strict adherence to regulatory guidelines are essential for building trust in the pharmaceutical industry. From research and development to manufacturing and marketing, every aspect of operations must be governed by a robust ethical framework and a culture of compliance.

Strategies to promote ethical and compliant practices include:

1. Implementing robust quality control measures and rigorous testing protocols to ensure product safety and efficacy.

2. Establishing comprehensive training programs to educate employees on relevant regulations and industry best practices.

3. Fostering a culture of integrity and accountability, with clear reporting channels for potential ethical breaches or concerns.

4. Collaborating with regulatory bodies and industry organizations to stay up-to-date with evolving guidelines and contribute to developing ethical standards.

By demonstrating a steadfast commitment to ethics and compliance, pharmaceutical companies can build trust with regulatory bodies, healthcare professionals, and the general public, contributing to a positive brand reputation.

Building Trust with Pharmaceutical Packaging

Pharmaceutical packaging goes beyond simply housing medication. It plays a crucial role in building trust with patients and consumers. Here's how:

• Packaging serves as a silent ambassador for a pharmaceutical brand, visually communicating its values and commitment to qualities like safety, innovation, and patient care. Thoughtful packaging design can instill a sense of trust and reliability in consumers.

Consider using clear and concise language on packaging labels, ensuring that essential information is easily accessible and understandable. Professional design elements, such as clean typography and a cohesive color palette, can convey a sense of expertise and attention to detail. Additionally, incorporating elements that evoke feelings of safety, such as prominent tamper-evident seals or child-resistant features, can further contribute to a trustworthy brand image.

• Tamper-evident features on pharmaceutical packaging are more than just a practical necessity; they are a powerful symbol of a brand's commitment to product safety and quality. In an industry where counterfeit products pose a significant threat to patient well-being, tamper-evident packaging assures consumers that they receive genuine medication from a trusted source.

Implementing advanced tamper-evident technologies, such as specialized seals, holograms, or RFID tags, can effectively deter counterfeiting and demonstrate a brand's dedication to safeguarding its products. Clear communication about these security features can further enhance consumer confidence, reinforcing that the brand prioritizes patient safety.

• In today's environmentally conscious society, sustainability is not just a buzzword but a key factor influencing consumer perceptions and brand loyalty. By embracing eco-friendly packaging practices, pharmaceutical companies can demonstrate their commitment to environmental stewardship and enhance their brand reputation.

Utilizing sustainable materials, such as recycled or plant-based plastics, can significantly reduce a brand's environmental impact. Minimizing excess packaging and incorporating innovative design solutions prioritizing material efficiency can create a more sustainable supply chain. Communicating these efforts through clear labeling and marketing campaigns can resonate with eco-conscious consumers and position a brand as a responsible corporate citizen.

Building Trust with AI

Pharmacovigilance, the practice of monitoring drug safety and detecting potential adverse effects, is a critical aspect of maintaining consumer trust in the pharmaceutical industry. Traditionally, pharmacovigilance has relied on reactive measures, such as analyzing reported adverse events after they occur.

However, AI-powered pharmacovigilance solutions can enable a more proactive approach. By analyzing vast amounts of data from clinical trials, social media, and other sources, AI algorithms can identify potential safety signals or patterns that may indicate emerging risks. This early detection allows pharmaceutical companies to investigate and address potential issues before they escalate, demonstrating a proactive commitment to patient safety and building trust with regulatory bodies and the public.

• AI and Brand Reputation Management

In today's digital age, consumer sentiment and brand perception are heavily influenced by online conversations and social media discourse. Monitoring and responding to these conversations promptly and effectively is crucial for maintaining a positive brand reputation.

AI-powered reputation management solutions can analyze vast amounts of social media data, online reviews, and customer feedback to identify potential brand reputation issues early on. By detecting emerging negative sentiment or misinformation campaigns, pharmaceutical companies can rapidly respond with accurate information, address concerns, and mitigate potential damage to their brand image.

Furthermore, AI can provide valuable insights into consumer perceptions and preferences, enabling pharmaceutical companies to tailor their messaging, product development, and marketing strategies to better align with patient needs and expectations, further enhancing trust and brand loyalty.

Building a Sustainable Reputation for Success

Building trust and a strong brand reputation in the pharmaceutical industry requires a multifaceted approach that spans all aspects of operations, from research and development to marketing and customer engagement. By embracing transparency, prioritizing patient needs, adhering to ethical practices, leveraging innovative packaging solutions, and harnessing the power of AI, pharmaceutical companies can establish themselves as trustworthy and reputable industry leaders.

A trustworthy brand can yield numerous benefits, including increased patient loyalty, smoother regulatory approvals, and improved sales and market share. Moreover, a brand reputation can attract top talent, facilitate partnerships and collaborations, and foster positive relationships with stakeholders, such as healthcare professionals, patient advocacy groups, and investors.

Conversely, a tarnished brand image can have severe consequences, including diminished consumer trust, legal troubles, and financial losses. In an industry where public perception can significantly impact success, neglecting brand reputation is a risk no pharmaceutical company can afford to take.

Conclusion

The evolving pharmaceutical landscape demands trust and a strong brand reputation. Today's informed consumers seek transparency, ethical practices, and a commitment to patient well-being. By embracing open communication, patient-centric drug development, and utilizing advanced AI-powered pharmacovigilance, pharmaceutical companies can position themselves as trustworthy and patient-centric organizations prioritizing safety, innovation, and responsible practices.

Author bio: Alissa Perry is an outreach coordinator at Backlinks Media. She helped the SEO agency with their link-building project.

Why is Data Management Important in Clinical Research?

In the realm of clinical research, precision and reliability are paramount. Precision and reliability, therefore, are driven by clinical trials, which in turn are driven by effective management. Effective data management, hence, stands as the cornerstone of success. 

From the start of a trial to sharing the results, every step relies on carefully gathering, organizing, and studying data. But why is managing data so important in this field? Let's take a closer look to understand why it matters so much.

1. Accuracy and Reliability

Clinical trials ensure that the science and medicine is constantly evolving to accommodate rapid changes in health in relation with environment and developing diseases.

At the heart of every clinical trial lies the pursuit of accurate and reliable data. This data serves as the bedrock upon which critical decisions are made regarding patient care, treatment efficacy, and regulatory approvals.

Clinical trial data management practices ensure that information is captured meticulously.  They aim to minimize errors and discrepancies that could compromise the integrity of the study.

By maintaining data accuracy, researchers can have confidence in their findings, paving the way for informed medical interventions and advancements.

2. Compliance with Regulatory Standards

The landscape of clinical research is governed by rigid regulatory standards aimed at safeguarding patient rights, privacy, and welfare. Adherence to these standards is strict. Robust data management plays a pivotal role in ensuring such compliance. 

By implementing secure protocols for data collection, storage, and sharing, research institutions can navigate the complex regulatory framework with confidence, mitigating the risk of non-compliance penalties and safeguarding the credibility of their studies.

It is beneficial for you and everyone, especially chronically patients to be informed of these rules and standards as well in order to be knowledgeable about your treatments from your end.

Not only that but also keeping up with changes in medicine allows you to know more about ongoing research in the medicine field and the ethics behind clinical trials and managements.

3. Efficient Trial Management

Clinical trial data management is an intricate affair. To ensure efficiency, their undertakings demand meticulous oversight and coordination across multiple stakeholders.

Effective data management, without compromising on quality or compliance, demands a centralized platform. This ensures that the data capture, monitoring, and analysis are done accurately. 

By consolidating disparate data sources into a unified system, researchers can gain real-time insights, identify emerging trends, and make timely adjustments to study protocols. 

4. Facilitation of Interdisciplinary Collaboration

In today's interconnected healthcare landscape, collaboration among diverse disciplines is essential for driving innovation and scientific discovery.

Data management serves as the anchor that enables seamless collaboration between clinicians, researchers, statisticians, and IT professionals. 

When interdisciplinary teams set up standard rules for sharing data and working together easily, they can use all their knowledge to solve difficult research problems faster. This helps them make important discoveries quicker and ultimately helps patients get better sooner.

5. Long-term Data Preservation

The things we learn from clinical research are really important and can be useful even after a study ends. Keeping data for a long time is crucial because it helps us do things like compare different studies, look back at past research, and make sure our findings stay true over time.

Moreover, past research and the methodology behind it are important backbones for future research. They not only help advance the research but also allow for mitigating any errors or developing past methods or stages to make future ones better. 

Good data management ensures that the information stays safe and easy to access for future scientists. This helps us keep learning and making medicine better for years to come.

6. Risk Mitigation and Quality Assurance

In the ever-changing world of clinical research, unexpected problems and risks are bound to pop up. However, good data management is like having a strong shield against these uncertainties. It puts in place strong checks and plans to make sure everything runs smoothly.

Imagine you're planning a big party. You'd check everything from the guest list to the food to ensure nothing goes wrong. In clinical research, it's similar. Good data management means double-checking everything to catch any mistakes before they become a problem.

Proactive management keeps everything on track, from making sure the data is correct to having backup plans in case something goes awry. It's like having a safety net to catch any issues before they cause problems. This way, studies can stay on schedule and meet their goals without any hiccups.

7. Ethical Considerations and Patient Trust

Central to the ethos of clinical research is a commitment to upholding ethical standards and fostering trust between researchers and participants. Transparent and responsible data management practices play a pivotal role in honoring this commitment. 

When research emphasizes keeping patients' information private, making sure they understand and agree to participate in a study, and keeping their data safe, people feel more comfortable participating. 

This means more people are likely to participate in clinical trials and research. When more people get involved, there's a bigger pool of information for scientists to study. This helps them learn more and make new discoveries, which can benefit everyone in society.

Conclusion 

Clinical trials and data management are crucial in scientific research. They're like the glue that holds everything together! It's paramount to ensure that the information is accurate and that all the rules are followed.

When data is managed well, it helps researchers learn new things and work together better.

Research institutions investing in good data management, basically means setting themselves up for success. It's like giving themselves the tools they need to make big discoveries and improve healthcare for everyone.

So, by taking care of their data, research institutions can open the door to new ideas and innovations in medicine.

This is a guest blog entry.

3 Types of Clinical Trials That Are Changing the World

There is good news for people with psoriasis, eczema, and Parkinson's. Recent clinical trials have shown that new treatments are on the horizon that could dramatically improve the quality of life for people with psoriasis, eczema, and Parkinson's.

These clinical trials are paving the way for new, more effective treatments for these conditions. They are also helping to speed up the process of getting those treatments to market.

If you or someone you love suffers from one of these conditions, it is important to stay informed about the latest clinical trials and how they could benefit you.

Read on and discover how these clinical trials are paving the way for better treatments.

Psoriasis Clinical Trials

Psoriasis clinical trials are increasingly providing medical professionals with valuable data to drastically improve the quality of treatments available to those suffering from this condition. 

Through objective and clinically meaningful metrics, medical practitioners are now able to accurately compare novel therapies against current treatment regimens. 

From this, medical professionals can identify which therapies provide the most effective and long-term care for those living with psoriasis. 

While physical measures of efficacy remain a priority in medical trials, the importance of assessing patient well-being through quality-of-life assessments is increasingly being recognized and understood as an essential component of successful medical trials. 

As medical trial research continues to develop, the medical world is improving their understanding of psoriasis every day, allowing them to provide better care for those affected by this condition.

Eczema Clinical Trials

Eczema, or atopic dermatitis, is an inflammatory skin condition in many people worldwide. It has a range of impacts on individuals and can leave them vulnerable to secondary infections. Medical researchers are conducting clinical trials better to understand the underlying causes and paths of eczema and to create new treatments to help people suffering from it. 

A greater comprehension of the immune system's contribution to eczema development is being attained through innovative research techniques. 

Genetic components are also being studied for potential preventative measures or treatments. By backing important research with clinical trials, we can improve the lives of those affected by eczema globally.

Parkinson’s Clinical Trials

Clinical trials for Parkinson's disease are making a positive, long-term impact on the world. The results of clinical trials can help improve our understanding of the disease, which is beneficial for both diagnosis and treatment, and can lead to the development of new drugs and therapies that may eventually lead to a cure.

In addition, participating in these trials offer Parkinson's patients the ability to benefit from treatments before they become widely available, without any cost attached. 

Moreover, individuals can remove themselves from the trial if desired and may even be extended opportunities for continued access after the study has concluded. These trials present an invaluable opportunity to progress our understanding of Parkinson's disease.

Conclusion

In conclusion, recent clinical trials for psoriasis, eczema, and Parkinson's are providing medical professionals with valuable data to improve the quality of treatments available for these conditions. 

These trials are helping to pave the way for new, more effective treatments and speeding up the process of getting those treatments to market. If you or someone you love suffers from one of these conditions, it is important to stay informed about the latest clinical trials and how they could benefit you. 

By participating in these clinical trials, we can improve our understanding of these conditions, develop new treatments, and improve the quality of life for those affected by these conditions.

This is a guest blog entry.

Career Options for Nurses with an Advanced Degree

If you are already working as a registered nurse or are planning to get into this career in the future, you may already be aware of the fact that nursing is a career choice with an endless array of options when it comes to career advancement and progression. Nursing is a career path with opportunities to move both sideways and upwards, with nurses able to choose to move into different specialty areas or work their way up the career ladder into management, leadership, education and advanced nursing positions.
 

Whether you’re already working as a nurse and want to progress or are thinking long-term when it comes to your nursing career, an advanced degree qualification is often essential for nurses who want to move up the career ladder. With nurses in higher demand than ever before and advanced nurses taking on more roles and responsibilities these days in order to fill the gap that has been left by the shortage of primary care physicians in the US, there are now more training programs and degree programs available for nurses who are interested in bettering their careers. 

In addition to a larger range of programs to choose from, nurses who are considering progression can also find more flexible options including online advanced nursing study, which is often designed with busy full-time registered nurses in mind. Today, nurses do not have to consider leaving their jobs or working part-time to accommodate for attending on-campus classes and lectures while getting their advanced degree, thanks to flexible and self-led online programs that allow the student to make his or her own decisions when it comes to when and how they’d like to study, making it easier to fit getting a master’s degree or doctorate in nursing around a busy healthcare career. Some of the best career opportunities for nurses with an advanced degree qualification include:

Nurse Practitioner:

The nurse practitioner role is currently one of the most popular advanced roles in nursing and it’s also one in very high demand. To become a nurse practitioner, you will need to be educated to an MSN or DNP level and, in some cases, earn a postgraduate nursing certificate that is designed to prepare you for advanced clinical practice. Nurse practitioners work in a variety of areas including family practice or working with specific patient populations such as pediatric, neonatal, adult-gerontology and psychiatric and mental health. In twenty US states, nurse practitioners are provided with full practice authority, allowing them to diagnose, treat, prescribe and have many of the same responsibilities and roles as a primary care doctor without requiring supervision. In other states, they still have the ability to do these roles; however, their decisions must be signed off by a doctor. 

Certified Nurse Midwife:

For nurses that are interested in women’s health and working with babies, a career as a certified nurse midwife could be one that is worth getting an advanced nursing degree for. A nurse midwife is an advanced practice nurse specializing in women’s health, particularly through the stages of pregnancy, birth, and postpartum. In addition to this, nurse midwives are active health professionals when it comes to providing primary and reproductive care for women in particular. They work in various different settings including within the community and in doctor’s offices, but are most commonly seen in hospitals in labor and delivery wards. 

Critical Care Nurse

Critical care nurses are advanced practice nurses who play an important role in caring for patients who are suffering with life-threatening injuries or illnesses. Critical care nurses will often work in hospitals and are typically found in the ICU departments or other areas where patients are acutely unwell such as the operating theatre or ER. Critical care nurses are required in any area of healthcare where patients might be found in life-threatening situations, including anywhere that needs high intensity interventions and a high level of around the clock nursing care. Recently, critical care nurses have played a vital role on COVID-19 departments particularly working with patients that have suffered badly with the virus and have required specialized care such as ventilation. 

Nurse Manager:

Nurse managers are responsible for overseeing the clinical operations of patient care units. They facilitate the work of healthcare professionals and ensure that the direct care provided to the patient is of the right standard and quality. A role as a nurse manager will typically require education to the MSN or DNP level and is less bedside-based and more administrative to that of a registered nurse or advanced practice registered nurse. Nurse managers are crucial for ensuring that the highest quality and standards of patient care are delivered and are often the loudest advocates for patients since representing unit needs to relevant stakeholders is often a key part of this role. 

Clinical Nurse Leader:

Clinical nurse leaders are advanced nurses who possess a high level of knowledge and clinical competence. Typically, clinical nurse leaders will work with a specific set of patients that they are assigned to, overseeing their care in the position of team leader. Clinical nurse leaders work in a role where they are required to regularly stay on top of the latest innovations and developments in healthcare, medical care and care delivery. They are responsible for putting evidence-based practice into action and ensuring that patients are provided with the highest standards of care. 

Nurse Executive:

Although nursing is a caring profession first and foremost, there are several opportunities to consider for those who are interested in working in a more management-focused career option. Nurse executives are senior-level nurses who are often in highly influential roles when it comes to shaping clinical practice. Nurse executives are often required to hold at least a Doctor of Nursing Practice qualification and their role involves defining strategic visions for success. They work collaboratively across the entire healthcare organization to ensure that patient care is of high quality and that both patients and employees report high satisfaction levels. In order to work at this level of nursing, you will need to have gained an advanced nursing degree along with management experience. Nurse executives are also required to be highly skilled in the operations management, human resources, and financial side of healthcare. 

Nurse Educator:

If you want an advanced nursing career role that will have a direct and positive impact on reducing the nursing shortage that we are experiencing in healthcare today, a role as a nurse educator might be an ideal option for you. Currently, one of the main reasons behind the increasingly worrying shortage of nurses in the US is due to the fact that there are simply not enough education professionals to prepare new nurses for the workforce fast enough. The problem is not that there are not enough people who want to become nurses – at some nursing schools and colleges, applicants are being turned away or having their enrolment deferred due to the simple fact that there aren’t enough people to teach them. To become a nurse educator and be influential in shaping the next generation of nurses, you will need to get a DNP qualification. This will prepare you for teaching nursing in formal educational settings to prepare students to become nurses or teach nurses who are looking to advance their careers further. 

Care Coordinator:

The role of a care coordinator is a relatively new one in the healthcare industry. This role is designed to focus mainly on the improvement of patient safety, care quality, and cost-effectiveness within patient care. Professionals who work in these roles are often nurses who take on the role of ensuring that the right type of care is being delivered to the patient at the right time. Care coordinators are also responsible for looking after transitions of care, such as moving patients to different departments, hospitals or clinics. They ensure that this is done smoothly without leading to any gaps in the patient’s treatment plan. Care coordinators are typically required to have at least a master’s degree in nursing and will usually work in collaboration with a variety of healthcare providers, equipment companies, insurance companies, and other organizations to ensure that patients receive uninterrupted, high-quality healthcare. 

Clinical Trial Nurse:

Clinical trials are consistently ongoing in order to improve our understanding of and develop new treatments for a wide variety of conditions. If you are interested in a career where you can be involved with the cutting edge of healthcare and make a difference to the healthcare of the future, you may want to consider a role as a clinical trial nurse. These nurses can be found working on large research studies designed to prove the efficacy and safety of new healthcare treatments including medication, devices, protocols and more. They have a variety of roles within clinical trials including coordinating research, ensuring the integrity of data, and providing treatment when needed to study participants along with ensuring that they are prepared for the trial. 

Getting an advanced nursing degree such as an MSN or DNP can lead to a wide range of advanced and lucrative nursing career options.

This is a guest blog entry.

The Essentials of Clinical Trial Data Management

Accurate and high-quality clinical data is of critical importance for every CRO medical company.

Effective clinical trial data management involves accuracy in data collection, data entry, data reporting and data validation.

Establishing and maintaining high standards of quality requires consistency in implementation across individuals and teams in the CRO medical organization.

Clear communication in data management can prevent costly mistakes by staff which can put the clinical trial at a huge risk.

The following clinical trial data management elements can help in improving a CRO medical company’s data management standards at every stage of the clinical trial.

Accurate and Relevant Data Collection

Standard practices need to be established by CRO medical companies to produce accurate and relevant data.

The methodologies used for clinical trial data management should be targeted towards the objectives of the clinical trial, resulting in an improvement in data quality.

This process will also help in the elimination of non-critical data. This is important because minimizing the risk of verifying such data lowers risk factors during endpoint analysis.

With the right guidance, clinical data integrity can be vastly improved and data quality variation among the individuals and teams in CRO medical companies can be significantly reduced.

Critical data points identification

Critical data points should be identified at the beginning of a clinical trial process. This requires determining which data needs to be measured in relation to achieving the end goal.

Fundamentally, clinical trial data management appears straightforward but the collection of non-critical data for purposes like patient safety can pose significant challenges.

It requires time and effort by the clinical trial data management team to ensure this data meets required qualified standards.

Aside from being able to identify additional data points, proper Standard Operating Procedures (SOPs) helps reduce the effort of data managers working with large volumes of data. This ultimately improves data quality.

Developing Standard Operating Procedures (SOPs)

Accurate and quality collection of clinical trial data helps minimize time spent in identifying and rectifying inaccurate data.

This requires a clear definition of responsibilities for each role as well as organizational practices.

This ensures uniformity in operations minimizes the chance of errors occurring and makes it easier to identify the cause of errors when they occur.

Standard Operating Procedures (SOPs) should be developed in collaboration with staff members.

This ensures everyone has a clear understanding of the tasks which are involved in the collection of data as well as the organizational practices.

This also provides an opportunity to identify deviations from best practices and document a course-correcting process which can correct these if they occur.

Educating Staff

A common hurdle found in clinical trial data management is the lack of industry-wide visibility in best practices. CROs create standard procedures of their own which makes it difficult to compare one organization’s management practices with similar organizations in the industry. As a result, there could be best practices which an organization may not have considered.

Educating staff members keeps them up-to-date on clinical trial data management processes which are practiced in the industry. It also keeps them motivated, builds confidence and raises their competency levels which lead to better results.

Using the Right Systems

In the process of developing SOPs which conform to industry best practices, it is important to look at constantly improving the quality of clinical data collection.

Collecting accurate and quality data is a key requirement of clinical trial biometrics data management and is largely dependent on the systems which are being implemented.

When managing data, the use of electronic data capture (EDC) systems should be considered to encourage staff to follow best practices. The systems should be easy-to-use and result in a reduction of potential errors when reporting.

An effective EDC system needs to be secure, minimize inaccurate data collection and allow data to be exported effectively. Some systems offer features such as edit checks,  audits, conditional forms, time point tolerances and allow medical coding language to diminish the potential for improper data entry and increase the integrity of your clinical data.

If the clinical trial involves investigational new drug (IND) testing, the EDC system should be validated and should also be compliant with 21 CFR Part 11.

In addition to all of this using the right systems also have other benefits such as meeting electronic signature requirements and robust communication with vendor systems. This elevates the value of clinical trial data for sponsors.

Steps Involved in Clinical Data Management

The following are steps involved in clinical trial data management:

Generating Source Data: This includes data such as patient diaries, medical records and laboratory results.

Transcription: In case paper Case Report Forms (CRFs) are used, clinical site records are transcribed onto these.

Data Entry: Data from the CRFs and other sources, are entered in the clinical trial database. Using
 Electronic CRFs (eCRFs) allows data entry from source documents directly to the database.

Data obtained from paper CRFs are generally entered twice and reconciled to reduce the error rate.

Data are always checked for accuracy, completeness and quality. This can require queries to be raised to the clinical site.

Locking: When data is considered final, the database is locked
 
Reformatting Data: For ease of analysis and reporting, listings, tables and figures are generated.

Data Analysis: Data is analyzed and reports are produced. Results are documented and additional high-level reports are produced. These include Clinical Study Reports (CSRs) and Investigator’s Brochures (IBs).

Archiving: Database and other study data are archived.

While these are the common steps which are followed, they are not necessarily in order. For example, longer studies commonly require generating intermediate discrepancies as well as listings to identify problems which need to be corrected before the study is completed.

This is a guest blog post.

5 Unbelievable (but incredible) Possibilities of Stem Cells Research

1. To bring someone back from the dead

Research currently underway by U.S Biotech company – Bioquark -  is hoping to bring brain dead patients back to consciousness.

The study taking place in India, will use implanted stem cells to regrow and stimulate neurons, and nerve stimulation techniques to jump start the nerves back into action. This technique has already been used to bring patients out of comas, and this is the next step.

Talking of the possibility of brain dead patients being able to make a full recovery, Ira Pastor Bioquark’s CEO has described it as;

“A bridge to that eventuality”

2. Reversing Heart damage

A long-term trial has shown the ability to reverse heart damage using engineered stem cells created by regenerative medicine company, Celixir.

The data collected over 5 years showed an average 40% reduction in heart damage. This is the first time that a study has shown heart scarring to be reversible.

Professor Westaby, from the John Radcliffe Hospital, Oxford, who has been working on the technique for more than a decade, said:

“I am very excited at the prospect of a trial which will hopefully lead to the availability of this stem cell treatment to thousands of patients annually in the UK.

This would be the biggest breakthrough since the first transplants three decades ago.”

This success story has paved the way for European and US regulators to agree to global trials involving 500 patients. Trials of more than 100 patients at two London hospitals are set to begin this autumn.

3. Restoring Eyesight 

Using induced pluripotent stem cells (iPS), a research team in Japan have stopped further deterioration of a woman’s sight – the first time that iPS cells have been used in this way.

The woman’s sight was suffering from macular degeneration - an age related deterioration of her eyesight. Induced pluripotent stem cells were placed on a patch in the eye, and then encouraged to form retinal pigment epithelial cells, which support and nourish the retina cells that capture light for vision.

The discovery of these iPS cells earned Shinya Yamanaka a Nobel Prize, as they can be formed from adult cells that are not stem cells.

“This is a landmark study and opens the door to similar treatments for many diseases,”

Shinya Yamanaka, director of the Center for iPS Cell Research and Application at Kyoto University, and Nobel Prize winner

4. An Alternative to Knee Surgery

Knee surgery is often the last resort for people with long-term knee injuries, but these can be fraught with complications, and often lead to decreased mobility.

However, a new clinical trial is testing a new approach  - filling the gap in a damaged knee cartilage with umbilical stem cells.

Sean Fair, from Massachusetts, U.S., has become one of the first people to have his injury treated in this way.

Gel containing the stem cells was injected into his knee in small holes drilled into the bone, along with the existing hole created by the accident.

Several months after the surgery, and after a strict rehabilitation process, the stem cells in Fair’s knee developed into chondrocytes, cells that secrete a matrix of cartilage, and sealed the hole in his knee. 

It is hoped that -  pending further trials - patients with knee injuries will be able to be treated with this method in the future, saving the agonising waiting and recovery times required for knee surgery.

5. To Treat Burns

An experimental technology using a device which sprays stem cells onto damaged skin, offers new hope to patients who have suffered a severe burn.

Patients with severe burns would usually have to wait for a skin graft which can be painful and require repeat procedures before it takes. The SkinGun created by U.S stem cell company, RenovaCare uses a solution made up of stem cells taken from the patient’s own body which attached to the skin and begins to grow as a cellular level.

"We don't modify the cells," said Thomas Bold, an engineer and president and CEO of RenovaCare.

 "We don't do anything with the cells. We just isolate them from the surrounding tissue, put them in a syringe within a water-based solution, and we spray them.

"What we're doing is all natural," he added.

This is a guest blog entry.

Top Medical News: Cheese Lowers BP, Bees Treat Prostate Cancer, Black Pepper Fights Fat, & More

Rather than navigating to a variety of websites to stay on top of the top daily medical news, try bookmarking the MedFriendly Blog and using this feature, where the day's top medical stories are compiled all in one place.
   
1. Cheese, please: Could a little Grana Padano drop your BP?: Integrating a type of Italian cheese, Grana Padano, into the usual diet of mildly hypertensive patients not taking any ACE inhibitors or angiotensin-receptor blockers (ARBs) resulted in a significant drop in mean blood pressure of 7 to 8 mm Hg compared with control patients, preliminary research shows.

2. Indian drug giant Cipla slashes cancer drug prices: Indian generic drug giant Cipla said Friday it had slashed by up to 76 percent prices of three anti-cancer medicines in what it called a "humanitarian" move and promised to cut the costs of more products.

3. Beastie Boy dead at 47: What is salivary gland cancer?: It's extremely rare for people to be diagnosed with salivary gland cancer. Most Americans who get it are older than 55.

4. Discrepancies on Medical Bills Can Leave a Credit Stain: As patients assume more of the responsibility for costs, complex billing and more aggressive collection by providers are resulting in negative credit report data that lingers for years.

5. Black Pepper May Help Fight Fat: Pungent Ingredient in Black Pepper Targets Fat Cells

6. Rising Obesity Rates Might Mean More Rheumatoid Arthritis: A new study suggests that severe weight gain might raise the risk for rheumatoid arthritis — a painful, chronic ailment — especially among obese women.

7. Nanotechnology In Medicine: Huge Potential, But What Are The Risks?: Nanotechnology promises to revolutionize drug delivery, gene therapy, diagnostics, and many areas of research, development and clinical application.

8. Amish farm kids remarkably immune to allergies-study: Amish children raised on rural farms in northern Indiana suffer from asthma and allergies less often even than Swiss farm kids, a group known to be relatively free from allergies, according to a new study.

9. Dental dilemma: Do kids need sealants?: Dental sealants are recommended for children when their permanent molars come in, but only a fraction of kids actually get them, say dentists who call the process one of the most under-used treatments to prevent decay in adult teeth.

10. Squirrel tests positive for plague at California campsite: A ground squirrel trapped at a popular campground in southern California has tested positive for plague.

11. Guidelines on cardiovascular disease prevention in clinical practice launched at EuroPRevent2012: The latest cardiovascular disease (CVD) prevention guidelines have been overhauled to produce a user friendly document with concise messages that awards greater weight than ever before to evidence from clinical trials and observational population studies.

12. FDA says study overestimated non-compliance with data-reporting laws: US drug regulator finds no evident harm caused by sponsors failing to post drug-trial data.

13. Beehive Extract Shows Potential as Prostate Cancer Treatment: An over-the-counter natural remedy derived from honeybee hives arrests the growth of prostate cancer cells and tumors in mice, according to a new paper from researchers at the University of Chicago Medicine.