article
07.08.2019

Four Key Factors in Choosing a CRO

As the healthcare and life sciences industries have moved toward outsourcing models in clinical research, pharmaceutical and biotechnology companies face the challenge of finding the right Contract Research Organization (CRO) to assist in the clinical development of their treatments and medical devices.

Although on the surface some services may seem similar, not all CROs are created equal. Clinical research needs vary tremendously based on the sponsor and the project itself. And finding the right partner with the areas of focus required for each unique project is of utmost importance. Below, we’ve listed some of the most important factors to consider in your CRO selection process.

1. Knowledge of Local Regulatory Environments
Regulatory expertise is a key consideration when selecting a CRO, especially in cases of international site selection strategies. The CRO you choose to work with should demonstrate a thorough knowledge of the regulatory environment where your study is conducted. Do they have in-house staff to ensure compliance with all international standards? What is their track record of clinical study approval with local governing bodies? Be sure that your CRO’s services include these types of regulatory support.

2. Access to the Right Patients
Patient enrollment capabilities are fundamental to your study’s success. Offshoring clinical trials offers a significant advantage in recruiting the right patients, but you will need to choose a CRO with access to appropriate sites for your study’s needs and parameters. Before selecting a CRO, make sure they provide a detailed feasibility assessment. During this process, be sure to evaluate your CRO’s site management service.

3. Therapeutic Area Expertise
Each clinical study is unique and requires a different set of skills and experience. When selecting a CRO, carefully consider their portfolio and level experience in your study’s therapeutic indication. An experienced CRO will be able to offer strategic insights and accelerate the clinical development of your product.

4. Timeline and Budget Adherence
A key reason for offshoring clinical trials is the need for efficient and cost effective clinical research solutions. It is important to know that the CRO services you enlist will fit the needs of your study. But it is equally critical to know that your CRO treats timeline and budget needs as seriously as your organization does. When vetting a CRO, look for sound risk management methodologies and communicate clearly to ensure timeline and budget goals are aligned from the start.

With the right CRO, you can achieve much greater efficiency in your clinical trials. To learn why OCT Clinical Trials could be the right partner for your organization, talk to an expert today.