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!

We had a great session yesterday with?Kristen K. Buck MD, our Senior Medical Advisor and a member of our Scientific Advisory Board. Kristen talked about?one of the toughest jobs in drug development:?being a?#ChiefMedicalOfficer?for a clinical stage biotech company. ? We work in a tough industry, and this is not an easy moment. Things move incredibly fast. People feel harried. Change is a constant. This makes?leading with #empathy?+ #curiosity a bigger challenge than ever. ? It also makes this more important. Walking in the shoes of clients and colleagues is critical to success. We asked Kristen to help us understand what keeps her, and her peers, up at night. ? In addition to being a key resource for?Biorasi?sponsors, Kristen serves as CMO and Head of R&D for?Lisata Therapeutics, Inc.?She shared lessons from the front lines, and she made two broader points I want to share: ? 1. Avoid surprises when you can, and bring thoughtful solutions when you can't. Change happens in?#clinicaltrials. The way we respond can mean the difference between success and failure.?Our responses can make meaningful impact on patients' lives. ? 2. Be brief. Be excellent. Be gone.?There's an old line that goes - "I'd have written you a shorter letter, but I didn't have the time." Take the time. Be concise. Value the time of your clients (and colleagues!). This was a great conversation. We'll do more of these with experts from key roles at sponsors. Recommendations appreciated! Thank you, Kristen!

When the CRA has seen the PI … only from a distance… Imagine this: You’re all set to meet the Principal Investigator and discuss the study, but instead, the Study Nurse walks in and says the PI is too busy to meet—maybe next visit. But uh-oh, you didn’t meet him during the last visit either, and the Report Reviewer has already raised concerns… Stressed, you go to grab a coffee, but the cup practically flies out of your hand as you catch a fleeting glimpse of the PI in the corridor! Well, TECHNICALLY, I HAVE SEEN HIM NOW—right? Fast forward to the monitoring report: “PI seen during visit. Confirmed. No further comments.” While this might sound humorous, it’s worth noting: seeing the PI for just one minute—or not seeing them at all after site activation—can be a strong indicator of why the site isn’t recruiting well or staying on track. Like, Follow and leave a comment! :) Cheers, Vitali #ClinicalResearch #CRA #MonitoringVisits #SiteVisits #HumorInResearch #ClinicalTrials __________________ Follow me on LinkedIn and subscribe to my newsletter on misterclinical.com

Patient perspectives and racial mistrust in #clinicalresearch >> https://bit.ly/410Zjg0

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!