Clinical Development
Expertise: Clinical Development 82 results
Clinical Development
Bringing an Oncology Asset to Market: In-House vs Outsource?
During the multifaceted journey of bringing a promising therapeutic to market, sponsors are faced with a critical choice—whether to manage asset development in-house or to outsource to a clinical research organization (CRO) partner. This decision can influence timelines, costs, control over the development process, and the likelihood of success. Understanding the pros and cons of…
Clinical Development
Sponsor Responsibilities Under ICH GCP E6: The Non-Negotiables for CRO Oversight
In the rapidly evolving landscape of clinical research, sponsors are under increasing pressure to conduct efficient, high-quality trials that meet stringent regulatory standards. The International Council for Harmonisation’s Good Clinical Practice (ICH GCP) E6 (R2) guidelines and the forthcoming E6 (R3) update outline the multifaceted responsibilities sponsors bear throughout the clinical trial process. Central to…
Clinical Development
Theodora O’Brien
Clinical Development
RAPS San Francisco Bay Area Chapter In-person 2025 Kick-Off Meeting
Clinical Development
COG UK
Clinical Development
OCT West Coast
The success of a clinical trial is contingent upon many factors, but the collaboration between contract research organization (CRO) physicians and principal investigators (PIs) is of growing importance in the industry. Choosing the right CRO partner is a pivotal decision for sponsors, just as selecting the right PIs is for CROs. Both choices are essential…
In the world of clinical research, diversity, equity, and inclusion (DEI) are not just buzzwords—they are essential pillars for advancing healthcare outcomes for all populations. Historically, clinical trials have often lacked diversity, leading to data gaps that can impact the effectiveness of treatments for underrepresented communities. Increasing access to clinical research is crucial not only…
Clinical Development