Industry knowledge, webinars and more for clinical research sites
Good Clinical Practices (GCP) requires that “essential documents” be filed at the sponsor and investigative sites in a timely manner. While the sponsor is responsible for establishing a Trial Master File (TMF), the site is responsible for the Investigator Site File (ISF), which many call the Regulatory Binder. A key part of creating a plan for...
Over the past four months, COVID has led to widespread changes across the clinical research industry, many of which will be carried forwards. 1. Changes in Clinical Trial Protocol & Design According to data collected by the Tufts Center for the Study of Drug Development (CSDD), as of May 20, 2020, more than half of...
To continue operating throughout the pandemic, research sites quickly implemented a variety of measures and procedures (i.e., PPE requirements, increased sanitation, COVID screening, IP handling systems, patient transportation systems, limitations on number of people on site, etc.). While these measures continue to be necessary, they have increased site workload and consequently led to an unprecedented level of financial strain....
In the latest segment of WCG’s COVID webinar series, Ms. Annick de Bruin compares the results of CISCRPs broad annual survey to the results of their new COVID-focused survey. Dr. Edith Mitchell also discusses the disproportionate impact of COVID on people of color and how we can take lessons learned in the pandemic to promote...
The impact of COVID-19 on clinical trials has likely become obvious for your site during this phase of the pandemic. Sites are struggling with screening holds, limited staff, an influx of sponsor requests while staff is not on-site, the challenge of retaining enrolled subjects, and more. It is now more important than ever to implement a business...
At the end of March 2020, Clinical SCORE conducted an online survey to gain insight on how the pandemic is affecting clinical research sites across the world. As the crisis is still evolving, the company conducted a similar questionnaire at the beginning of May to obtain a more updated picture of clinical trial sites and to compare...
Coronavirus is disrupting clinical research at sites worldwide. To further understand how COVID is affecting research at a site level, CRIO connected with Dr. Marcus Stone, the Director of Clinical Research at The Spine Institute of Louisiana Foundation, the research arm of a broader spine institute. The Foundation was created solely to identify and test...
Clinical Research IO‘s recent web survey found that COVID-19 is disrupting clinical research sites worldwide. The results are indicative of a significant slowdown in new drug development and long term effects on healthcare in general. 25% of sites have stopped recruiting Of the 75% that are continuing enrollment, about half (37%) are considering halting new...
In early March 2020, Clinical Research IO conducted a clinical trial industry survey and found that COVID-19 is disrupting clinical research operations at all 73 participating sites. As the situation continues to evolve, sites are forced to constantly adapt. The majority have halted new patient enrollment for ongoing studies but will continue to conduct visits...
Webinar Date: February 17, 2020 Webinar Guests: Mark Ragusa, former Director of Research at Raleigh Neurology Associates Don’t do clinical trial business development haphazardly. Mark Ragusa, former Director of Research at Raleigh Neurology, shares his framework for systematically targeting and nurturing your sponsor and CRO relationships to create a rich, site-appropriate study pipeline. Raleigh Neurology...
It is no secret that CRA turnover is a huge issue in the clinical research industry. It is not uncommon for sponsors or CROs to spend thousands of dollars onboarding a CRA, only to have them leave within one to two years after starting. Recent reports from the ACRP1 show that CRA turnover rates were as...
Boston, MA – The Delegation of Authority log is one of the “Essential Documents” in clinical research. In the DOA log, the Principal Investigator delegates study-specific duties to different members of the research study team. Each duty has a start and end date and should be signed off by both the Principal Investigator and individual...
