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Get the latest updates, insights and best practices on data management and biostatistics in clinical trials.

Best Practices in Data Management: Bioforum Simplifies Complexity and Successfully Delivers Quality EDC for First-in-Human Clinical Trial Sponsored by Dren Bio

Bioforum and Dren Bio (“Dren”) joined forces to focus on Dren’s first clinical trial evaluating DR-01 in patients with large granular lymphocytic leukemia or cytotoxic lymphomas in January 2022. DR-01, the California-based biotech’s first asset to enter clinical studies, is a monoclonal antibody designed to bind to a receptor selectively expressed on cytotoxic cells involved in a variety …

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Unlocking the Power of Data with a Data – Focused Biometrics CRO

In today’s evolving clinical research and drug development landscape, with more data sources and technology involved than ever, choosing a data-focused, specialty biometrics contract research organization (CRO) over a full-service CRO can significantly improve the efficiency and success of your trials. While full-service CROs offer a comprehensive range of services, these vendors remain primarily focused …

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Audit trails are a regulatory requirement. How to take an RBQM approach.

Audit trails are a regulatory requirement. How to take an RBQM approach. Audit trails have long been a regulatory requirement, proving to be a very important historical record of data recorded for clinical trials. These records facilitate transparency and accountability by allowing researchers, sponsors, and regulatory authorities to trace and verify the validity of the …

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CRO Collaboration that Fuels Innovation for Specialty Biotechs: Bioforum and Veramed Join Forces to Deliver Complementary Expertise and Capabilities

For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies, as well as nonprofits and academic medical centers, outsourcing is a necessity. It often isn’t feasible or cost effective to conduct all clinical trial operations – from study design through submission – in house. For that reason, when it comes …

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Lean Medical Writing Post 1: The Lean Movement and Medical Writing

By Dionne Crafford Word economy contributes to streamlined documents. Yet the process of “lean” embodies so much more. In 1913 Henry Ford created “flow production”, but the process allowed only limited variety. Toyota birthed the process of lean by revisiting Ford’s way of thinking. The process was distilled into five principles: identify value (customer perspective), …

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A revised version of ICH E6 has been issued for review

By Fadwa Dabbah-Assadi Since 2016, emerging technological innovations have made clinical trial designs more diverse and complex, and increase the risk that stakeholders may fail to comply with the present/former E6(R2) guidelines.1 Consequently, the E6(R2) guideline was amended to the E6(R3) guideline (endorsed on 19 May 2023) by the International Council for Harmonisation of Technical …

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Bioforum & Abiomed Partnership Case Study: How A Long-Term Data Services Partnership Drives Efficiency for A Medical Device Trial Sponsor

Background In October 2022, Abiomed, a leading provider of medical technology focused on mechanical circulatory support heart and lung recovery, announced that the U.S. Food and Drug Administration (FDA) accepted and closed all of the post-approval study reports related to the pre-market approvals (PMA) for the Impella heart pump. The announcement marked a significant regulatory …

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5 REASONS YOUR COMPANY NEEDS A CDM CONSULTANT

By Nadia Nahmany Clinical trials are a critical step in the drug development process, and the effective management of data plays a crucial role in their success. After all, data forms the building blocks of information used to evaluate the safety and efficacy of new drugs and medical devices. The FDA, for example, outlines its …

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The Key to Effective and Productive Medical Writing

By Dionne Crafford What criteria would need to be achieved for medical writing to be considered effective? Medical writing must be accurate (free of error) and concise (brief and free of superfluous detail), yet still engaging. The writer needs to convey a complex message to a target audience clearly and logically for interpretation. To be …

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