4 Tips for Managing Supplemental Vendors During Early Clinical Development

Finding a contract research organization that has all the resources and processes in place to perform your clinical trials can be a challenge. Early clinical development, especially during a Phase 1 clinical trial, can set the pace, standards, and trajectory for the rest of your drug development program. Therefore, it is crucial that you make sure your CRO has access to all essential resources, processes and employs robust quality standards. Here are some tips to effectively identify and partner with a contract research organization.

 

Make Sure Your CRO Has Access to the Right Equipment

When selecting a CRO to partner with, you need to investigate whether your chosen CRO have safe and fully equipped Phase 1 clinical trial units to perform every test on-site. This could include equipment for MRIs, biopsies, x-rays, telemetry, ultrasounds, and other assessment or tests. A simple discussion of the clinical protocol and study endpoints with your CRO can ensure your trial runs smoothly. In the event that the CRO outsources some of the tests to specialized vendors, it is important to ask for vendor qualifications.

Check Vendor Qualifications

When the CRO you choose uses a specialized vendor, it is important to ensure all qualification audits have been completed. Failure to review vendor qualification reports prior to starting your first in human clinical trials could be detrimental to the trial outcome. Ideally, qualification assessments will be as comprehensive as possible, usually involving the CRO’s Quality department. The level of qualification can depend on how involved the vendor will be in your clinical trial. A qualification assessment involves collecting information on licensure and certification, resource availability to handle volume, reporting structure, contingency planning, issue escalation flow, internal SOPs, workflow, compliance with industry regulations, negotiation and contract processes, and experience with similar projects.

Who Will Manage the Vendor?

Communication between the CRO you partnered with and a third party vendor is essential. Asking about workflow is useful in understanding how the CRO manages a vendor’s responsibilities during the conduct of clinical studies. The question is: Who will manage the vendor? Will it be the CRO’s project manager? Is there a subject matter expert who can handle the work or will someone in your organization be managing? Is the vendor part of a preferred vendor relationship with your organization as the sponsor or with the CRO? There is no one correct answer, but these are questions that require answers to move forward with the clinical trial. Ultimately, it should be assigned to the person who is communicating trial objectives and expectations with vendors most frequently throughout the project.

Vendor Performance Evaluations

When your clinical study is complete, your team and the CRO should review the vendor’s performance and apply lessons learned from the study to future research. Typically, this is necessary if you intend to continue using a specific vendor for additional clinical trials or if the vendor’s contribution to the study was significant.

About Altasciences

Altasciences is a mid-size CRO/CDMO offering pharmaceutical and biotechnology companies a proven, flexible, full-service approach to preclinical and clinical pharmacology studies, including program management, medical writing, biostatistics, clinical monitoring, data management, formulation, manufacturing, and analytical services, all customizable to specific sponsor requirements. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences ensures the design and conduct of first in human clinical trials and early efficacy studies generate the data that meets the sponsor’s objectives, leveraging preclinical data in the design of the programs that move the drug candidate to proof of concept. Bringing full-service solutions to sponsors, Altasciences provides access to essential resources for early clinical development, including their 250,000-square-foot clinical pharmacology units (CPUs) with over 580 beds for Phase 1 clinical trials. Complete with state-of-the-art bioanalytical laboratories, Altasciences is also recognized as an industry leader in Asian Ethnobridging clinical studies, specifically with Japanese participants.

Learn more about partnering with Altasciences for a clinical trial at https://www.altasciences.com/