CRO Selection and Qualification

Selecting the right Contract Research Organization (CRO) is critical to successfully complete your clinical trials.

A dependable CRO will guarantee good data quality, regulatory compliance, and efficient work.

Why Choose BioBoston Consulting for CRO Selection & Qualification?

Clinical Trials Expertise

From the beginning of our clinical trial experience, we have monitored hundreds of trials. We know what it means to work with CROs and can guide you in picking the right partner for your program.

Rigorous Qualification Process

We are keenly aware of the potential for error, so we adopt rigorous standards to prevent them. Our evaluation of potential CROs combine assessments of capability, how well previous work has been performed, and what type of performance records they have had into a comprehensive picture that takes all uncertainties out.

Our process covers technical audits, quality evaluations and regulatory compliance review thus ensuring that the CRO is thoroughly prepared to conduct your clinical trial.

Focus on Regulatory Compliance

We make certain that all our selected CROs comply with applicable regulatory standards, including those of the ICH-GCP (International Conference on Harmonization of Good Clinical Practice) and its notes such as FDA, EMA, etc. Regulations are consulted so that all the requirements current to that time are in fact met.

CRO Selection

We understand that each clinical trial is different. Our CRO selection procedure is made to measure your specific program needs, from early-phase studies through late-stage clinical trials; to guarantee the perfect fit for your therapeutic area, geography and regulatory demands.

In addition to recommending the right CRO. We will rate potential CROs according to their expertise, resources and experience in your domain & area for more detailed evaluation, check geographic scope of operation.

CRO Qualification Assessments

We will conduct a complete audit to assess the quality systems, day-to-day workings, performance on regulatory fronts and compliance with GCP as well any other key guidelines.

Risk Assessment & Management. We will examine risks which might lie with the CROs’ performance compliance operational strength then we will come up with strategy ideas for reducing these contracting risks. Ensuring that the contract you negotiate with your selected CRO is clear about what you expect from your partners, what your deliverables should be and the terms of your clinical trials objectives.

CRO monitoring

When the clinical trial begins, we will keep on looking at how well the CRO is performing to help you get successful results. By assuring that your timelines, quality requirements, and compliance with regulations are met, we will keep you on track and things will go smoothly.We carefully oversee the CRO’s performance from start to finish.

Completed

Get successful results in your clinical trials by relying on our expert team of experts for help in selecting and managing the right CRO. 

Contact Us for your own personal consultation on how BioBoston Consulting can help with CRO selection and qualification needs