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Biometrics services (data management, biostatistics, data standards, and statistical programming) can be outsourced together as a unit or individually with different CRO partners. While splitting services up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the data management and biostatistical/programming components for your clinical trial project or program.

Since the introduction of the original 3+3 method, the available design options for dose escalation in early phase studies have expanded beyond traditional algorithm-based designs to include model-based designs.

Oncology dose-escalation trials are a distinct entity, with nuances and considerations which set them apart from other therapeutic areas. From varying trial designs to the patients who participate, dose-finding clinical trials in oncology are a clinical research paradigm. Understanding strategies to facilitate success is key to study planning and execution, from feasibility to site selection through enrollment and treatment.

Clinical pharmacology is an important cornerstone of the clinical development of drugs, which this blog post has only begun to introduce.  Future blog posts will focus on various aspects of clinical pharmacology, including the types of studies that comprise a clinical pharmacology program, a comparison of clinical pharmacology programs for large and small molecules, evaluations of drug interactions, and regulatory considerations for clinical pharmacology.

Information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data.

While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.

The development of a gene therapy (GT) product has many considerations that differ from those of a traditional biologic or new chemical entity (NCE) program.

For a drug to be used in a human clinical trial, analytical testing must be performed to demonstrate the suitability of the drug for use. These tests ensure the identity, quality, strength, purity, and potency of an active substance and drug product or biologic and must be scientifically sound and validated to demonstrate their suitability for the defined use.

A look at Decentralized Clinical Trials (DCT) beyond the pandemic-what we’ve accomplished and where we are heading.

An estimand framework has been presented by the ICH in November 2019 and the FDA in May 2021 to provide clarity on defining the reported treatment effect. This blog post summarizes the key components to the estimand framework that are covered in the ICH E9 (Revision 1) addendum on estimands and sensitivity analyses in clinical trials, as well as the supporting FDA guidance and ICH training material.