Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
What is the cost of a failed partnership between a pharma company and its CROs? Is it financial? Research and development time?
Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle? Or do you work at a sponsor or CRO where you feel sites are making up study budget numbers or are never happy with any budget proposal?
In this article, I’ll share insights on how sponsors and CROs set up overall study budgets and discuss five secrets to getting your dream budget approved.
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.
Based on Amazon’s approach to building its business, it is logical to conclude that the online retailer would be an amazing CRO. Amazon’s competitive strategy is to aggressively discount prices to win market share. Plus, its customer obsession and disruptive innovation are second to none. Let’s imagine what an Amazon-run CRO would look like.
Fall conference season is upon us and a cursory internet search shows no less than a half-dozen conferences focused on the topic of patient-centricity. Thankfully, the momentum around the topic continues as sponsors and CROs strive to find more patient-centric approaches to conducting clinical trials.
The past several years have brought significant changes to the clinical trial landscape. Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.