Ron Squarer believes for a company to be successful, especially in a capital-intensive area such as biotechnology, it has to know what it is good at and target those skills. Squarer is the CEO of Array BioPharma, a company focused on the discovery, development, and commercialization of targeted, small-molecule drugs to treat patients with cancer.
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.
Six leading CROs, along with cloud-computing vendor Veeva Systems, have banded together to form Align Clinical CRO, a new industry standards group that hopes to make it easier for CROs and sponsors to work together. But Align Clinical CRO is not the first attempt to bring standards to the information discrepancies that arise between sponsors and CROs during clinical trials.
The clinical operations team at CSL Behring has come a long way in the six and a half years since Mark Ridge joined the organization. The company is now executing on its goal of being a sponsor of choice for patients, sites, and CROs.
Consumer awareness of the quality of goods purchased is good practice in any industry, but in biotech and pharma, it is a regulatory requirement. One of the most common goods we purchase in this industry is a vendor’s services — their time, effort, and resources. Whether it be a lab, CRO, or data management group, the FDA mandates we, as sponsor companies, know the quality of the goods and services we purchase from them.
A problem that seems to impact everyone involved in clinical research is the current shortage of CRAs. This problem is causing excessive turnover at CROs, climbing CRA wages, and frustration for sponsors who have to deal with changing staff members at their CRO. Can a new partnership help solve the problem?
Dan Peres, SVP and head of medical for Immuron, works with a pipeline that includes treatments for ASH, Diabetes, C-Diff, Colitis, NASH, and UPEC. Peres recently spoke to me about the challenges of performing trials and the process of scaling up to a large, Phase 3 study.
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?
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.
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