Phase 1 clinical trials are a pivotal step in developing new therapies. These early-stage studies involve a small number of healthy volunteers or patients, and are crucial for assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of new drugs. Given the complexity and regulatory requirements of early phase studies, partnering with a Contract Research Organization (CRO) specializing in phase 1 studies can be valuable.

The benefits of working with a phase 1 CRO specialist

Partnering with a phase 1 CRO gives you access to specialized knowledge and experience essential for the successful execution of your early-stage clinical trial. Experienced phase 1 CROs ensure that study designs are scientifically robust and compliant with regulatory requirements, guiding you through the complex landscape of approvals and submissions. They can also help alleviate the burden of recruitment – a common challenge in phase 1 trials – through their strong relationships with study sites and investigators. Taking advantage of their existing networks can streamline the identification, screening, and enrollment process, ensuring that your trial begins on schedule.

From a financial perspective, partnering with a phase 1 CRO specialist can lead to significant time and cost savings. CROs with early phase experience can leverage their established processes, systems, and expertise, allowing sponsors to focus on core research and development activities. For example, at Southern Star Research, we already have experienced phase 1 trial staff working in gold standard systems, eliminating the need to set up in new processes or train new personnel when taking on phase 1 studies. This efficiency in resource allocation, combined with our ability to manage complex trial procedures and documentation, makes our team a worthwhile and cost-effective partner in the early stages of clinical development.

How to choose the right phase 1 CRO specialist

Selecting the right phase 1 CRO partner involves a thorough evaluation of several factors, including:

Therapeutic area expertise

Many phase 1 trials now include patients in the dataset, so one of the critical aspects to consider is the CRO's expertise in the specific therapeutic area relevant to your trial. CROs with deep therapeutic knowledge, such as in oncology, neurology, or dermatology, understand the underlying mechanisms of the disease, and the way it is treated. This knowledge allows them to partner with you to design more effective and targeted trials. What’s more, each therapeutic area may have distinct regulatory requirements and expectations. Awareness of this at the outset can ensure your trial complies with all regulatory standards and reduce the risk of delays.

Experience with trial complexity

The complexity of your phase 1 trial is another crucial factor in selecting a CRO. Complex trials often require specialized procedures, technologies, and more extensive commitment from sites and participants. For example, some phase 1 trials may involve intensive pharmacokinetic sampling, biomarker analyses, or the use of advanced imaging techniques, and adaptive designs. A phase 1 CRO with relevant experience can manage these intricacies more effectively.

Cost transparency

Cost is always a critical consideration, as clinical trials can be resource-intensive. A clear understanding of your financial commitments when working with a CRO is essential to balancing quality with budget constraints. You want to choose a CRO that provides a detailed and itemized budget. This transparency helps you understand where funds are allocated and allows for better financial planning and management.

While it’s also worth evaluating whether your CRO offers competitive pricing for their services, it’s equally important to prioritise quality. Lower costs may reflect a compromise in quality. Instead, it’s better to ensure that your chosen CRO’s pricing is fair, and reflects the expertise and resources they bring to the trial.

Key criteria to evaluate phase 1 CROs

Request and evaluate proposals

Request detailed proposals from your shortlisted CROs. Proposals should include:

• Clear roles and responsibilities for each task.
• Detailed timelines, milestones, and deliverables.
• Transparent and itemized budget breakdowns of service fees and other costs.
• Past performance and case studies – evidence of successful phase 1 trials using similar designs and/or in similar therapeutic areas.

Visit sites and assess facilities

Determine whether your prospective CRO has worked with your potential site/s before. Do they need to conduct site visits to assess the facilities, and meet the trial team, or do they have enough information already at hand to support your selection? Regardless, if your trial is complex, an on-site visit to comprehensively evaluate the clinical unit/s, laboratories, and overall infrastructure is best practice.

Negotiate contracts

Carefully negotiate contracts to define the scope of work, deliverables, timelines, and payment terms. Ensure the contract includes:

• Clear responsibilities: Defined roles and responsibilities of both your role and that of your CRO.
• Contingency plans: Provisions for handling unexpected issues or delays that may impact contracted activities.

Healthy volunteers vs. patients

Many phase 1 trials involve healthy volunteers to assess basic pharmacokinetics and safety. Ensure your phase 1 CRO can recommend a site with efficient recruitment strategies to enroll the necessary participants quickly, as well as having the required space and facilities to manage confinement periods, food intake, and sample collection. Robust safety monitoring systems should also be in place to manage and mitigate potential adverse effects, ensuring participant safety while gathering essential pharmacokinetics and data.

For early phase trials involving patients, careful site selection is essential to ensure patients are accessible and eligible for your study. Additionally, intelligent trial design becomes even more critical to account for the added complexities of early phase testing in patients, where multiple confounding factors need to be accounted for due to concomitant conditions and therapies. This requires collection of a lot of data, and a strong focus on the welfare of your participants to ensure a full dataset can be obtained. All of this must be clearly outlined in your trial design, and during a thorough informed consent process.

Choosing the right phase 1 CRO specialist is a critical decision that can significantly impact the success of your study. By rigorously evaluating potential partners, you can find the right CRO that meets your needs and enables you to build a solid foundation for subsequent trial phases. If you want to learn more about how you can successfully navigate early phase clinical trials with a team of professionals committed to safe and ethical studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.