Drastic changes in drug development mean quality management approaches are more critical than ever, with meaningful advancement hinging on cultural shifts, crossfunctional alignment and top-down approaches within organizations, as well as thoughtful, stakeholder-informed trial designs.
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Boehringer Ingelheim (BI) has done a full 180-degree turn on patient involvement in trial design in recent years, moving from virtually no patient input to incorporating patient feedback in nearly all of its protocols today. The German pharma giant elaborated on how it accomplished this during a session at the 2024 Summit for Clinical Ops Executives (SCOPE).
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The demand for clinical development professionals continues to outpace supply. To meet this challenge, organizations are increasingly turning to FSP models to outsource specific functions of clinical trials (e.g., clinical operations, pharmacovigilance, etc.). In a recent survey by the PPD clinical research business of Thermo Fisher Scientific, 41 percent of respondents reported increased use of FSP models compared to the full-service outsourcing (FSO) model’s 29 percent growth. This demand surge for FSP professionals calls for bespoke recruitment strategies that combine the agility of an FSP with the deep internal talent pool that is the hallmark of an FSO arrangement.
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Patient recruitment costs were estimated at $9.4 billion and rising in 2022, according to a report by Roots Analysis, a pharma and biotech market research company. Although recruitment is often perceived as a challenge due in part to the associated costs, it is not itself a problem that needs solving, but rather a critical component at the heart of reaching a study’s end goals. By the time a study reaches the active recruitment of participants, significant R&D investments and countless hours of researchers’ valuable time have been made. Patient recruitment is a crucial step in clinical research that determines the success of a study and can often be the rate limiter.
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The upcoming Avoca Quality Consortium (AQC) Summit will play host to valuable insights on the most impactful changes clinical trials are going through today. Chief among those are survey findings about industry’s awareness of ICH E6(R3) and the effect these revisions will have on trials.
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