Choosing the Right Site Certification Provider: A Practical Checklist for Clinical Research Sites

More clinical research sites are exploring certification to formally embed and demonstrate quality, strengthen sponsor confidence, and differentiate themselves in an increasingly competitive landscape. But not every certification serves the same purpose and not all certification programs are created equal. Choosing the right certification for your site or site network, and choosing to do it at the right time is far more important than choosing any certification. If you are currently evaluating research site certification options, how do you choose the right provider? Below are some practical steps and a due diligence checklist to help guide your review and decision making:

Firstly - Be Clear about Your Purpose

Different certifications exist for different purposes. Holding one certification or accreditation does not preclude pursuing another - in fact, they are often complementary. Each assessment framework brings a distinct lens to quality, governance, and operational excellence, enabling sites to demonstrate excellence across a broader range of operational areas and achieve deeper, more integrated quality standards. Some certifications are regional mandatory requirements whilst others are pursued voluntarily and proactively based on specific drivers.

Ask yourself: • What are we trying to achieve? • Are we seeking reassurance - or elevation of quality and reputation? • Is this about compliance, or competitive positioning? • Are we being reactive (to previous challenges) or proactive (to achieve future goals)? • Are we looking to streamline and centralize processes to support scalable growth? It may be one, or a combination of all of the above, or something else. Clarity here will prevent misalignment later.

Due Diligence Checklist when Evaluating Certification Providers

1. Is the Certification Recognized and Credible?

• How long has the provider been established? • What is their reputation in delivering quality standards, certification and accreditation? • Are assessors qualified and experienced? • Is the provider independent and impartial? • Can the provider supply references from sites who have completed the process? • Is the certification recognised by the industry?

2. Scope and Reach

• Is the standard regional or global? • In which countries is the Certification active? • Is the standard industry-specific to the clinical research industry or is it generic?

3. Strategic Alignment

• What is the purpose of the standard? What are the key areas of focus? • Is that purpose closely aligned with your site’s vision and long-term goals?

4. Development & Governance

• How was the quality standard developed - industry consultation or internal design? • Who determined the assessment criteria? • Is there a clear governance and appeals structure? • Is the standard mapped to global best practice frameworks? How was the framework determined? • Is there provision for continuous evolution of the standard?

5. Does It Go Beyond a Tick Box Audit?

Some programs focus purely on document review – others assess real-world operational capability. Ask: • Does the process assess how your site actually operates? • How is the evidence collated and evaluated? The strongest certifications assess quality culture, not just paperwork.

6. Is the Assessment Process Transparent?

You should understand: • How long does the process take; what are the key steps/milestones? • Who will be involved in the process (from the site side)? • Who will be conducting the process (from the provider side)? • What happens if gaps are identified? • What support and guidance is provided throughout the certification journey? • What happens after certification is awarded?

7. Does the Provider Offer Development Support – Not just report findings?

Certification should be a growth opportunity. Consider: • Do they provide feedback and comprehensive guidance/actions for improvement? • Is there a remediation pathway? • Do they support continuous improvement post-certification? Some providers position certification as a ‘quality journey’ rather than a pass/fail event.

8. What Does Certification Actually Give You?

Beyond the certification itself, ask: • Will it strengthen internal quality systems? • Will improve capacity and efficiency? • Will it provide foundations for scalable growth / centralized operations? • Will it differentiate your site competitively and help you attract more studies?

9. Stakeholder and Community Value

• What ongoing support, community access, or value-add is provided beyond the certification itself? • Which respected stakeholder groups or organizations are involved?

10. What Is the Long-Term Model?

Sustainable certification programs include: • Periodic or scheduled reassessment, and structured renewal pathways. • Reflection on results and quality improvement outcomes. • Actions and recommendations to support continual quality improvement and long-term excellence.

11. “Right Fit” and “Right Timing”

Certification often involves close partnership with the provider as you work collaboratively through the process. It requires: • Leadership commitment • Staff engagement • Resource allocation • Time availability The timing must be right. The strategic intent must be clear. The provider relationship must be aligned. Certification should feel like a positive step forward - not an administrative burden. NOTE: If your site has unresolved GCP compliance concerns, recent inspection findings, or internal quality system weaknesses, the priority should be addressing those first. Certification should build on a strong compliance foundation, not replace it.

Some Final Thoughts

Research site certification should never be just a marketing exercise alone. It should be about: • Building sponsor/CRO confidence • Embedding and evidencing quality and demonstrating commitment to continuous improvement • Strengthening operational resilience and improving efficiency • Enhancing Participant experience and outcomes • Supporting long-term scalable growth. Choose the certification that aligns with your strategy, supports your evolution, and positions your site for sustainable excellence. The right certification, at the right time, with the right provider, can be transformative. The wrong one can simply become another administrative exercise.

About GCSA Site Certification – The Global Quality Standard for Clinical Research Sites

GCSA is the world’s only internationally recognized global quality standard and certification for clinical trial sites, that focuses on the business operations that are critical to the delivery of high-quality clinical trials. Developed in direct response to demand from sponsors and CROs for a quality standard that would identify high-performing sites from a business and partner perspective, GCSA Site Certification enables sites to achieve and formally demonstrate business operational excellence and capacity to deliver world-class clinical trials. The standard was developed by IAOCR in close consultation with a Global Advisory Board which included key stakeholders from sponsors, CROs, commercial and public health sites and Government organizations. To learn more visit: https://iaocr.com/en/gcsa-clinical-trial-site-certification

If you would like to arrange an introductory call please contact: Vicki Booth - Director of Marketing and Partnerships Email: vbooth@iaocr.com www.IAOCR.com