Biorasi

Doff your caps to our CEO Chris O'Brien on teaching his first Harvard Business School class. The entire Biorasi #OneTeam is very proud!

PTO for NJ #clinicaltrial participants >> https://bit.ly/4956Egv

A Neglected Cornerstone of Clinical Trials: Investigator Site File ? One of the most overlooked yet critical aspects of site management is the regular review of the Investigator Site File (ISF). Despite its importance, ISF neglect is a common issue, leading to findings and challenges during: ??? Audits: Missing documents or outdated versions. ??? TMF Checks: Inconsistent filing with the Trial Master File. ??? Metrics Reviews: Unclear tracking of site progress and compliance. ?? Site Findings: Avoidable discrepancies impacting trial quality. ? Why Does This Happen? ?? - Time Constraints ? - Lack of Training ? - Bad Process ? I’ve found that the root cause often lies in an overly complicated ISF-TMF checklist, which makes it difficult for the CRA to perform a quick and simple check. This complexity often leads to distress, delays, and excuses to shift focus to other priority tasks at the site. ? How Can We Improve? ?? Bring on an experienced team to design an ISF-TMF checklist that doesn’t require an energy drink to figure out where to pick up. The checklist must clearly show: ? Which documents have been checked in the past, ? Which are pending, and ? Which are new since the last visit. Additionally, the fields for CRAs to check must be straightforward, enabling the review to be completed easily within 30 minutes to 1 hour per visit. This approach will ensure regular checks, eliminate backlogs, and improve site compliance. ? What has been your experience with ISF maintenance? ?? Share your thoughts and tips below! ? #ClinicalResearch #InvestigatorSiteFile #ISF #TMF #Audits #ClinicalTrialManagement #SiteQuality

Compounding interest: The FDA and #GLP1 pricing >> https://bit.ly/3Zgg0TB

Its YOUR turn to tell: What Makes a Clinical Trial Successful? ?? Clinical trials are the cornerstone of medical progress, but their success doesn’t happen by chance. If you ask 10 people to give you 4 most important key points that matter, do you think you'll get the same answer? I THINK 1. A Well-Thought-Out Protocol Clear objectives, robust methodology, and compliance with regulatory standards are essential. Without a solid foundation, even the best teams can struggle. 2. Qualified Investigators and Sites Experienced investigators and well-equipped sites are essential for smooth trial operations and accurate data collection. 3. Suitable and Motivated Participants Engaged participants are the heart of every trial. Their motivation ensures higher retention rates and reliable outcomes. 4. Correct Execution with Valid Data Clean data, and adherence to protocols ensure reliable results and regulatory approval. What do you think is the most challenging factor in ensuring a trial’s success? Share your thoughts below! ?? #ClinicalResearch #ClinicalTrials #GCP #HealthcareInnovation #ResearchExcellence #ClinicalOperations __________________ Follow me on LinkedIn and subscribe to my newsletter on misterclinical.com Cheers! Vitali

#TrialGPT introduces #LLMs to patient recruitment >> https://lnkd.in/e_ayRUpr

Bruce Booth & Atlas Venture are out with their annual year-in-review for #biotech & #pharma. As usual, it's full of interesting stuff, but I was really struck by this slide that shows the hill biopharma companies are climbing. Over the past decade, the average cost to develop a therapy is up by $1 billion. At the same time, success rates have fallen, as has the average value of an approved drug. The science right now is incredibly exciting. Crossed fingers that the other variables required for success -- regulatory frameworks, IP protection, interest rates, etc. -- incentivize break through treatments in 2025 and beyond. The whole presentation is worth your time. https://lnkd.in/eEzQEwDK Recommended, Biorasi!

Did you select a bad site? When a site badly wants to participate in a clinical trial and makes golden promises at the Site Selection Visit: “We promise top-notch quality, fast enrollment, and perfect compliance!” A few months into the study: Monitor arrives to find missing source docs, overdue queries, and a mysterious ‘lost’ study kit. Managing clinical trials means navigating these gaps between expectations and reality. That is why feasibility process and selection is crucial for success of the trial. It’s not just about setting goals—it’s about consistent follow-through, collaboration, and troubleshooting along the way. Have you ever encountered a site that over-promised but… let’s say, under-delivered? Share your stories below, I’m sure we’ve all been there! #ClinicalResearch #ClinicalTrials #SiteManagement #MonitoringChallenges __________________ Follow me on LinkedIn and subscribe to my newsletter on misterclinical.com Cheers! Vitali

Move it! Physical activity improves cognitive health >> https://bit.ly/3UY6GRE

Great insight from Biorasi's Vitali Hoffmann.