Data standards support the robust organization, analysis, and reporting of clinical trials and many regulatory authorities mandate the use of standardized data structures for clinical trial submissions. The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) is a framework used to represent trial data in a standardized format for review. The SDTM …
If you’re contemplating a Functional Service Provision (FSP) model to enhance your biometric team, understanding successful implementations can offer valuable insights. Here are three in-depth case studies showcasing the versatility and effectiveness of the FSP approach in addressing various needs in biometrics: Case Study 1: Pharmaceutical Company – Fractional Data Management FSP Business Need: …
Choosing to supplement your internal biometrics team via Functional Service Provision (FSP) offers numerous benefits, including long-term stability without the administrative burden of direct employment. However, building a successful partnership with your FSP provider requires careful planning and communication. Here are six key steps to consider: Kick-Off Meeting: Initiate the partnership with a formal …
Pharma and biotech companies often face the challenge of needing additional biometrics support, whether due to a full outsourcing strategy, slow hiring processes, or busy periods with conflicting priorities. When addressing this gap, two common approaches are project-based outsourcing (PBS) and Functional Service Provision (FSP). PBS involves outsourcing some or all biometrics components bundled …
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 …
Selecting the right Contract Research Organization (CRO) is a critical decision for any pharmaceutical, biotech, or healthcare company. While the focus is frequently on the clinical operations components, the success of a clinical trial can hinge on the reliability and accuracy of the biometrics activities: data collection, management, and reporting. To support your best outcome, …
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 …
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 …
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 …
By Dionne Crafford In the first of two posts on lean medical writing, we were introduced to the lean thought process, its origins, why it would be beneficial to apply it to medical writing, and how it can be applied in an authoring context. In this second post, we will look at specific strategies we …
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), …
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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