Whitepapers

With new technology and groundbreaking medical devices being introduced every week, there’s never been a more exciting time to be involved in clinical research. Even during the coronavirus pandemic, the pace of innovation has only accelerated. 

This article discusses strategies for finding the best cultural fit for a biopharmaceutical company, and the positive impact it has on implementing a successful FSP model, driving efficiency and continuity.

To attract research opportunities, organizations must start studies quickly, deliver promised enrollment, and produce quality research data. Discover ways to streamline and fortify your research administration program in this paper.

While the FDA has issued guidance to help sponsors, investigators and IRBs decide on the best ways to protect patients while keeping their trial moving, the decision is ultimately up to each individual research team. IMARC has assisted research teams with remote monitoring, auditing and other activities for years. More recently, our team helped one company transition to an entirely remote clinical trial. We wanted to share this example to show it can be done, under certain circumstances and with careful consideration.

Virtual elements in clinical trials require extra considerations All teams involved should maintain ongoing dialogue and collaboration for success A discussion with industry leaders provides insight into such trials

This white paper describes the complexity of GI trials in detail and shows how a therapeutic specific data capture solution can overcome their significant, but typical, challenges. Clinical Ink’s intimate knowledge of and experience with GI trials enables a better deployment experience and improved trial conduct.

• How to decide which devices are best-suited for patients participating in a clinical study • Data transmission and interaction from wearables during the study • Regulatory considerations for wearable devices across different countries/ geographical regions

For investigative sites, selecting studies for increased patient centricity, whether through decentralized trials, patient input in study design, or remote monitoring initiatives, can improve enrollment.

To attract research opportunities, organizations must start studies quickly, deliver promised enrollment, and produce quality research data. Discover ways to streamline and fortify your research administration program in this paper.

⦁ The need to re-examine and adapt clinical operations to ensure patient safety ⦁ How to communicate with regulators and comply with fast-changing regulations

As the COVID-19 outbreak continues to spread globally, we need to keep participants safe and studies moving forward. Read this eBook to learn how.

To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review, as well as BIMO Inspection Metrics detailing the most common findings by fiscal year.

- Advantages of manufacturing immuno-oncology therapies in multiproduct facilities - Preventing cross-contamination and proper cleaning validation

Traditional paper-based processes are rapidly being replaced with electronic tools for more efficient and accurate clinical trials conduct. This whitepaper will help research sites prepare for the electronic future.

This whitepaper offers readers tips on how to improve the data quality in dermatology trials using a unique, three-pronged approach.

Traditional paper-based processes are rapidly being replaced with electronic tools for more efficient and accurate clinical trials conduct. This whitepaper will help research sites prepare for the electronic future.

Learn the benefits of an approach that focuses on risks to the most critical data elements and processes of each study and how effective data integration is the foundation.

This eBook is a guide for researchers to show how Electronic Clinical Outcome Assessment (eCOA) solutions can be utilized in global Central Nervous System (CNS) clinical trials. Overview of CNS trials, challenges faced, and eCOA benefits and use cases

This whitepaper outlines the most important criteria investors look for when evaluating the investment potential of a pipeline compound and the company behind it.

Electronic Clinical Outcome Assessments, or eCOA, employs technology such as smartphones, tablets and personal computers to allow patients, clinicians, and their caregivers to directly report outcomes eCOA produces highly accurate data that allows for a better understanding of the patient experience in clinical trials and; ultimately helps simplify the path to approval.

Antimicrobial resistance remains a health and financial danger worldwide. Vaccines can both help reduce disease and combat antimicrobial resistance. Despite advancements, making antibacterial vaccines remains challenging.

This whitepaper outlines the most important criteria investors look for when evaluating the investment potential of a pipeline compound and the company behind it.

• Using up-to-date data ensures budget accuracy for clinical trials. • Budgets require tools for cost savings, defendable processes, and more. • GrantPlan enables budgeting teams to keep costs at fair market value.

• Managing the financial aspects of sponsor–payer–clinical site relationships • Case study and implications: investigator payments issues

As biopharmaceutical companies form partnerships with vendors for R&D, they can learn important lessons about outsourcing from the vastly different experiences of Toyota, Honda and their American counterparts.

• Practical considerations for ePRO implementation during trials • Future of eCOA and oncology PRO instruments • Approaches for improving PRO in oncology trials

All clinical trial activities are required to follow Good Clinical Practice (GCP) principles. Learn how to be "inspection ready" at all times.