Whitepapers

Discover how a small pharmaceutical company leveraged unified visualizations and reporting into study data to save $50M in study costs and months in development time.

Insmed had a late-breaking strategy change that challenged their timelines. Learn how they incorporated significant protocol changes and still hit their FPI deadline.

Which new developments can help jump-start breakthroughs in immuno-oncology research? Understand the key scientific drivers, read peer-reviewed research, and get actionable ideas that can spur innovation in this must-read paper for clinical leaders.

In the wake of COVID-19, clinical research sites are in dire need of extra resources to help run their clinical trials. By utilizing qualified, experienced WCG Clinical Research Coordinators (CRCs), these professionals can help overburdened study teams get tasks done, and get them done with efficiency and precision.

Discover how a small pharmaceutical company leveraged unified visualizations and reporting into study data to save $50M in study costs and months in development time.

Private practices tap into an industry investing more than $15 billion annually in the USA. These five recommendations help practices capitalize on potential benefits.

Cerba Research initiated custom kit building & distribution for an infectious disease study, during the COVID-19 pandemic, in 10 days. A typical timeline is 8 weeks.

Find out how traditional trial modalities have evolved to participant-centric virtual platforms and how to best engage your IRB in this Advarra-Science 37 collaboration.

Incorporating genetics into rare disease clinical trials is both effective and challenging. This white paper offers strategies for successful implementation.

Cerba Research initiated custom kit building & distribution for an infectious disease study, during the COVID-19 pandemic, in 10 days. A typical timeline is 8 weeks.

Decentralized or hybrid trial models have not been widely adopted in clinical research until now. See how COVID-19 is ushering in a new era of clinical research.

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