COVID-19 lessons are still being learned, however, some are already here to stay, and the data focus is one of them. At Bioforum, we have been privileged to be ahead of the curve in terms of data mastery and led several sponsors on this data-focused journey, especially helping medical teams better understand their data assets …
Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner In September 2021, the FDA issued a notification to the biopharmaceutical industry alerting them that multiple clinical studies conducted by two India-based CROs were “not acceptable” because of data integrity concerns. Following inspections conducted in 2019 at the CROs’ …
Check out Applied Clinical Trials Magazine for Our Chief Data Strategists & Solutions Officer Tanya du Plessis’ recent interview with Irit. Gliko-Kabir, BioLineRx’s Vice President of Clinical Operations. She discusses BioLineRx’s partnership with Bioforum and journey developing a potential standard-of-care mobilization agent for autologous bone-marrow transplantation. Irit also shares insights on how the right outsourcing partnership models can help small, …
When a patient presents with a fever or what appears to be an acute infection, clinicians face a seemingly simple question: should antibiotics be prescribed or not? Distinguishing between bacterial and viral infections is a major diagnostic challenge because the symptoms are often very similar. Beyond an ineffective treatment for viral infections, prescription of antibiotics, …
PolyPid Ltd. is a Phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enabling precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical …
Tanya du Plessis, VP Data Solutions and Strategies at Bioforum and Rich Davies, VP Solutions Expert at CluePoints, explain how to apply the principles of RBQM to Data Management and the benefits of a risk-based approach. Increased Pressures in Clinical Data Management RBQM plays an important part in the way clinical trials are run today. …
Regulatory authorities specify that “the sponsor is ultimately responsible for the validation of the computerised system and for providing adequate documented evidence on the validation process.” Put simply, a sponsor is required to ensure that there is sufficient evidence proving that the platform or system used for clinical trial data collection and management is fit …
Writing a winning grant proposal is not an easy task. This series of tips aims to provide the main ‘ingredients’ that will make your grant proposal a successful one. Aim for funding opportunities with the highest success rates. There are many funding opportunities available for submission, some local, some international. Many funding organizations will list …
The research is done, the writing is complete, and every word in the project has been scrutinized dozens, sometimes hundreds, of times over. After so much collective effort, this must surely be the best version, right? Unfortunately, even though the study team strives to maintain quality throughout every step of clinical studies, research documents must …
A few years ago, when I was a staff member in a clinical research site, I always found the study protocol to be a very dependable reference. When I needed information about the activities to be performed at each visit or how to best classify the intensity of adverse event and protocol deviations, I could …
In this blog post, I want to take a look at technical problems that might arise when writing molecular biology articles if not properly proofread. Once the long-awaited moment of writing the last sentence of the manuscript arrives, many scientists fail to proofread their work closely. This may result from overexposure to one’s own text …
In partnership with Applied Clinical Trials, our VP of Data Strategies & Solutions Tanya du Plessis explores key outsourcing strategies and decisions for small emerging biopharmas. Last month, Tanya discussed how to avoid and reduce the impact of momentum-breaking clinical trial amendments, and how choosing the right electronic data capture (EDC) system to collect and …