Selecting a Contract Research Organisation (CRO) is one of the most important decisions a Sponsor will make in the planning and delivery of any clinical trial. The right partner will help ensure your study is well-executed, timelines are maintained and take a huge operational weight off your shoulders. A poor fit can result in delays, rising costs and missed milestones.
But with so many CROs out there, how do you know which one is the right choice for your trial?
To identify a reliable partner, Sponsors should look beyond capability checklists and ask direct, practical questions. Here are five questions every sponsor should be asking before making that choice.
1. Have you delivered studies comparable to ours?
Therapeutic experience is important but so is familiarity with the operational and regulatory requirements of your specific study type.
For example, early-phase studies usually need a CRO that has access to clinical units, knows how to manage safety closely, and has experience running dose escalation trials. Later-phase studies, especially those with lots of sites, are more about coordinating across different countries, using systems that can handle larger volumes of data and working with sites that can recruit well and stay engaged.
Sponsors should ask for concrete examples of similar studies the CRO has supported. This includes information on design, indication, patient population and region. It is also reasonable to ask what challenges were encountered and how they were addressed. A CRO that is open about its experience is more likely to be a dependable partner.
2. Who will manage our study, and how will communication be handled?
Project success often depends on effective communication. It is essential to understand who your main points of contact will be and what communication processes are in place.
Will you have a single point of contact? How frequently will you get updates? What happens if something goes wrong?
Sponsors should clarify who will oversee the trial, who will manage day-to-day delivery and how frequently updates will be provided. Some prefer weekly conferences with full metrics while others prefer brief written summaries focused on key risks and decisions.
Timely escalation of issues is also essential. If a new risk is identified, the Sponsor should be notified early with a clear summary of the issue and potential mitigations. A CRO that withholds concerns until problems escalate can significantly disrupt study timelines. Look for transparency, responsiveness and a willingness to adapt to your preferred ways of working.
3. What’s your approach to patient recruitment and retention?
Patient recruitment remains one of the most common causes of study delay. It is not sufficient for a CRO to say they will recruit on time. They must be able to explain how.
Sponsors should ask whether the CRO owns clinical sites, has access to patient databases or uses external referral networks. If recruitment is outsourced to sites alone, what additional support does the CRO provide to meet enrolment targets?
Retention should also be addressed. What strategies are in place to reduce dropouts? For longer studies or those with frequent visits, patient engagement becomes increasingly important. Supporting materials, flexible scheduling and site-level engagement strategies can all contribute to stronger retention.
4. How do you manage quality and ensure compliance throughout the study?
Every CRO will claim to prioritise quality, but Sponsors should investigate how this is implemented in practice.
Begin by asking about the CRO’s recent audit history, including outcomes from Sponsor audits or regulatory inspections. Transparency in this area is a positive sign. Sponsors should also enquire about how protocol deviations are tracked and resolved, and how oversight is maintained across different regions and vendors.
A strong quality culture is reflected in timely documentation, site support and attention to detail. Sponsors should look for evidence that issues are not only identified but also followed up with meaningful action. Routine training, internal audits and regular data reviews are all good indicators of operational quality.
5. Are your services adaptable to our specific requirements?
Some Sponsors do not require a full-service CRO. They may already have vendors in place, established systems or a preferred group of clinical sites. In these cases, the CRO must be willing to integrate with what already exists rather than insisting on a fixed model.
Sponsors should ask whether the CRO can support individual functions such as data management or monitoring, without requiring end-to-end ownership. They should also explore how the CRO approaches changes in scope and whether additional support can be added later without major disruption.
A CRO that cannot adapt once the study is underway may create unnecessary delays or internal pressure for the Sponsor.
Making the Right CRO Choice
There’s no such thing as a perfect CRO but there is such a thing as the right CRO for your trial. Aim to find a partner that understands your study, communicates effectively and can deliver consistently under real-world conditions.
At MAC Clinical Research, we work closely with Sponsors to conduct trials that are realistic, efficient, and aligned with their objectives. As a full-service CRO with over 30 years of experience, we own and operate our own clinical units, giving us direct control over trial conduct, timelines and the patient experience including our state-of-the-art, MHRA-accredited Early Phase Unit. We also contract with investigator sites globally and recommend a strategy that blends our own high-performing sites with the best external sites to deliver successful outcomes for your study.
Our purpose-built national Recruitment Contact Centre, in-house database of over 250,000 registered volunteers and proprietary recruitment system allow us to recruit the right patients quickly and accurately. Especially for studies with challenging inclusion criteria or fast timelines.
If you are planning an upcoming trial and would like to explore if we are the right fit, please get in touch here.
