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Get the latest updates, insights and best practices on data management and biostatistics in clinical trials.
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How Small Biotechs Can Overcome Study Execution Challenges and Achieve Big Results
How Small Biotechs Can Overcome Study Execution Challenges and Achieve Big Results

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, …

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Case Study: Enabling A New Frontier in Infectious Disease Patient Management  with Comprehensive Clinical Data Management
Case Study: Enabling A New Frontier in Infectious Disease Patient Management with Comprehensive Clinical Data Management

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, …

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Bioforum and Medidata: Trusted Long-term Partners that Sponsors can Depend on - A Case Study with PolyPid
Bioforum and Medidata: Trusted Long-term Partners that Sponsors can Depend on – A Case Study with PolyPid

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 …

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Using Risk-Based Monitoring To Focus On What Matters
Using Risk-Based Monitoring To Focus On What Matters

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. …

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CSV (Computer System Validation): You don’t have to suffer
CSV (Computer System Validation): You don’t have to suffer

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 …

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Tips For Writing a Winning Grant Proposal - Part 1
Tips For Writing a Winning Grant Proposal – Part 1

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 …

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A Brief Overview of the Quality Checking Process
A Brief Overview of the Quality Checking Process

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 …

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