By Daniela Kamir Academic manuscripts generally require revision following initial submission. If the authors, agree to implement revisions, it is good practice to prioritize the requested tasks to tackle the revision process as efficiently as possible. Take the revision process as an opportunity to improve your manuscript with the help of experienced professionals. A scientific …
Managing a multi-stakeholder writing project Research and development in the pharma and medical device industries involve many stakeholders (e.g., regulatory affairs, clinical, biometrics, clinical pharmacology, CMC, non-clinical), and thus a regulatory document almost always has multiple authors. Writing a regulatory document with multiple collaborators can be chaotic and time-consuming. Adopting a few of the principles …
The Five KYSes for Getting the Best Out of Your Medical Writing Vendor We often focus on what vendors should do in order to consistently deliver high-quality documents on time. There are, however, many things that the client can do to enhance the chances of getting what they need, when they need it. After …
By Danielle Hadar When starting QC work on a document, I first look through the entire document and its formatting to see if anything is out of place, whether the heading numbers are correct according to the E3 ICH Guidelines or if they need to be reorganized, and if the tables and figures are sequentially …
By Eyal Wultz, President & Co-Founder, and Bremer Louw, Vice President, Biometrics Operations & Business Development, Bioforum Data capture, analysis, and reporting are critical activities during the clinical trial process, as this information provides clinical researchers with a reliable and high-quality source for validating a product’s successes and failures. Yet, without a standardized method for …
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 …
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