As medical writers, staying ahead of regulatory changes is crucial. The shift from ICH E6 R2 to ICH E6 R3 brings several updates that we need to be aware of to ensure our documentation remains compliant and effective. Here’s a breakdown of the key differences and their impact on our work. Embracing Risk-Based Approaches ICH …
Introduction With over 50%[1] of drugs in development reflecting rare/orphan and oncology indications alone, the complexity amongst patient cohorts is real with the patient identification-recruitment-enrolment bottleneck becoming the single greatest critical factor (as if it wasn’t already) in the success of any clinical program. It is little wonder we are witnessing the proliferation of patient …
Drug development is a high-stakes, high-cost endeavor. Every new drug entering clinical trials requires careful decision-making, particularly regarding trial design and resource allocation. However, when biopharmaceutical companies invest excessive resources into a single drug, they risk sidelining other potentially life-saving treatments. This short-sighted approach can result in missed opportunities for patients and significant financial loss …
Value of strategic statistical consultants Many sponsors are restricting the utilization of strategic statistical consultants to sample size calculations. By doing so, they are limiting the value they receive. Statisticians are best positioned to build a bigger picture in their minds and assess larger impacts of decisions made at various stages of development on ultimate …
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 …