10 Questions a Biotech Startup should ask before Selecting a CRO

selecting a cro
selecting a cro

To bring new therapies to market, biopharma companies engage contract research organizations (CROs) for their expertise in navigating the complex landscape of drug development and regulatory pathways. The selection of a CRO depends on the experience, areas of expertise, geographical reach, and importantly, the ability of the CRO to meet the sponsor’s clinical objectives. If you are an emerging biopharma company or a biotech start-up, you are well aware that your needs are unique, and finding the right CRO is of critical importance. Here are some questions that can guide your choice.

1. What trial-related services are required?

Compatibility: In the drug development cycle, biotech start-ups may find working with CROs necessary to tap into clinical trial management expertise and therapy experience that they are still building up internally. The question then is what trial-related duties and functions are needed, and specifically, what unique clinical services and support needed for the trial. Finding the right CRO goes beyond capabilities as there are also benefits in a small biopharma company working with a small CRO with similar corporate culture and values.

2. What experience and capabilities does the CRO have?

Capabilities: Now that you have a shortlist of prospective CROs able to deliver what you need, ask if they have relevant experience in running similar trials – in design, geography, and therapeutic area – and if they have successfully adopted technology to improve clinical trial performance. Small CROs like Vial offer a high degree of specialization in specific disease areas and geographic focus and are also poised to adopt the latest technologies, identify opportunities for application, and provide insights on how the tech may be deployed.

3. Does the CRO have a Quality Assurance process?

Compliance and Quality: Ensure that the prospective CRO has a quality assurance management system that complies with regulations, and that ensures they deliver the quality of service promised while meeting your clinical objectives.

4. Does the CRO communicate well?

Communication: Be sure you are on the same page in terms of communication expectations – how and how often will the CRO communicate with your internal teams? Equally important, be sure the CRO keeps you informed of unanticipated barriers or changes and how you will work together to overcome the underlying causes. In complex clinical trials, sponsors need a CRO team with expertise at all levels and who pay enough attention to detail. Changes in the team may result in extended timelines as well as disruption at research sites. Smaller CROs tend to have a much lower turnover compared to large CROs, providing the stability and continuity sponsors need.

5. How does the CRO address challenges during a trial?

Customization: Aware that the clinical trial process may encounter challenges at different stages, sponsors need transparency, flexibility, and problem-solving skills from a CRO. Smaller CROs offer more flexibility for customization and can propose and jointly execute out-of-the-box solutions. Smaller biopharma companies embarking on drug development for the first time may rely on CROs like Vial with experience in their targeted therapeutic area(s), who understand regulatory approval challenges, and can provide tactical and strategic support.

6. What do clients say about the CRO?

Client Satisfaction: As you evaluate prospective CROs, determine what their client satisfaction record is by asking for success metrics. For example, sponsors needing cost certainty should verify the CRO’s track record in meeting timelines, keeping within budget, and its policy on change orders. For client satisfaction, undivided attention and a high-touch relationship with CROs, small CROs can offer close contact, good oversight, and a more personal experience. In a partner-like model, small CROs are responsive and mindful of their emerging biopharma client needs.

7. Will the CRO outsource and how will they maintain service quality?

Commitment: Determine if the CRO will outsource or subcontract parts of the clinical trial operations and if so, investigate how they plan to do it. Ascertain their commitment to ensuring that you receive the quality of service promised and that your clinical objectives are met. Fully committed to its mission to run higher-quality clinical trials with faster execution, Vial has invested heavily in developing its own unique technology products and services. The Vial clinical trial management system (CTMS), VialConnect is an example of tech-enabled clinical trials to improve trial performance.

8. What is the CRO relationship with patients?

Connections: Advancements in digital health technologies enable a shift from site-centric to patient-centric clinical trials with the aim of reducing patient burden, improving treatment adherence, fostering patient engagement, and enabling higher-quality, faster, and more frequent data collection. CROs like Vial recognize the potential of such trials and have developed technology to design and operate patient-centric trials. The Vial electronic patient-reported outcome (ePRO) is a consumer-grade, mobile patient experience that is compliant and customizable for patients in a trial. It is an electronic system that allows patients to directly report the status of their health condition through computers or mobile devices and may be in the form of electronic diaries or questionnaires.

9. How will patient input be used to develop the trial?

Criteria for Eligibility: How does the CRO determine trial eligibility criteria with realistic recruitment and retention targets? Establish if the prospective CRO has a plan to research and engage with patients to develop a good understanding of the target trial patient population. If applicable to your trial, determine if the CRO has experience in adaptive trial design to ensure patients most likely to benefit from treatment are enrolled.

10. Does the CRO have international trial experience?

Coverage: If yours is a clinical trial to be conducted across multiple countries and regions, seek a CRO with experience managing clinical trials in your target locations. Local rules and regulations for clinical research vary and an experienced CRO can help mitigate barriers to the successful completion of trials.

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