In today’s rapidly evolving clinical research market, it’s important to be sure you’re partnering with the right company to provide you with the expert clinical trial endpoint services you need to advance your drug program. If you aren’t sure an endpoint partner is right for your company, consider reviewing our article, Five Reasons to Partner with a Specialty Clinical Endpoint Expert. When you’re ready to choose an endpoint service provider, we recommend you start with the following five questions.
What are the key questions to ask before choosing an endpoint service provider?
1. What is the company’s experience and expertise in your therapeutic area?
This may seem like a no-brainer, but one of the biggest advantages of working with an endpoint expert is that the company focuses on your clinical trial endpoints of interest. Make sure to ask how many clinical studies the company has provided services for, the credentials of their scientific and medical team, and the disease states they have worked with.
2. How deep is their bench of study experts trained in industry-sponsored clinical trials?
Ask what transparency they provide in ensuring the team you’re assigned is tenured and will reflect your company’s priorities. Will they provide fast and flexible responses to the changing needs in your program? Often the level of expertise of the team who is trying to win your business is of a much higher caliber than who you will be working with day to day. Find out who will supervise your project and who is ultimately responsible for ensuring your study is on-time and on-budget. What credentials and experience do they have? They should have a dedicated project team for your study that can be contacted with a single phone call, as well as a team of readily accessible subject matter experts.
3. What Quality Assurance structures does the company have in place?
Make sure the company has a thoroughly documented and audit-ready Quality Assurance framework to support regulatory compliance for clinical trial data including HIPAA, GDPR, and 21 CFR Part 11 at a minimum. Confirm your clinical trial endpoint data will stand up to intense regulatory scrutiny by asking about the company’s experience with FDA and other regulatory submissions. Ask to review SOPs and policies as part of your sponsor audit.
4. Does the company offer a secure and validated technology platform that provides ongoing access to your data?
Some companies make you wait until the end of your study for a data transfer without providing transparency and progress reports throughout. Ideally all study stakeholders – from site to data reviewer to sponsor – have access to the current study data on an ongoing basis. In some cases, companies can work with APIs that can connect your data to your data warehouse. Ask how many studies their technology has supported and what it offers in terms of data redundancy and backup, authentication protocols, and firewall and data encryption.
5. Does the company focus on partnerships, regardless of study size?
How important will your relationship be to this endpoint service provider? Some large endpoint service providers have so many clients they are working with, your project may seem like a tiny cog in a big machine. Confirm the provider you’re considering prioritizes a collaborative, partnership-driven approach for all projects.
Some companies tend to overpromise and underdeliver, which puts your study success at risk. If you’re looking for a clinical endpoint service provider that will value your partnership and make your study a priority, consider MERIT.
BENEFITS TO PARTNERING WITH MERIT
- Transparent communication with prompt access to in-house experts
- Deep bench of project managers, trained in industry sponsored clinical trials
- Experienced and tenured staff with a dedicated team of specialists for every project
- Standardized processes for site certification, data DICOMization, reader variability monitoring, and data output. This reduces data variability and risk by providing higher quality data
- EXCELSIOR™, our cloud-based software solution, is designed for imaging studies and is FDA 510(K) approved and HIPAA, 21 CFR Part 11, and GDPR compliant
- Proven track record supporting FDA submissions
- Experienced and trusted R&D partner
We understand the drug discovery process is complex and demanding, and the clinical stage is resource-intensive and high-risk. With over 300 trials supported, MERIT has the proven experience to help you accelerate your product development. Our specialized expertise informs every facet of our relationship with you, making our partnerships simpler and more efficient.
Connect with us to learn more about how our expertise and approach can support bringing your product to market on-time and on-budget.