Compliant clinical trial platforms : sure, but why, and how?

State-of-the-art trial enrollment digital platforms have to be “compliant”. So is the Allyfe platform, but instead of listing all the technical features which contribute to it, let’s talk about the fundamental approach the Allyfe technical team has taken to reach compliance, and the reasons why this approach is the most sustainable and efficient.

While devising their enrollment platform, the Allyfe team knew they had to make compliance as robust and dynamic as possible. That is why they took the time to analyze why it had to be compliant. They put themselves in the shoes of successively a research site investigator, of a sponsor, of a CRO, all subject to specific legal and regulatory constraints and requirements. They then decided to adopt a functional risk-based approach: what are the major risks these stakeholders face in their operational process, as far as data management, privacy, security is concerned and how can the platform mitigate these risks?

Let’s develop this modus operandi with Jean-François Lecocq, Allyfe’s chief compliance officer:

When we mention legal and regulatory requirements affecting clinical trials, what are wetalking about?

Theclinical trial market is global now. That is why the Allyfe team chose to select the strictest and most demanding EU, U.S. and international requirements, just to make sure the platform could be used for trials throughout the world with the same level of security. I am thinking about GDPR(General Data Protection Regulation); of course, but also about GCP (Good Clinical Practices) and more generally about GXP (encompassing GCP, GMP-Good Manufacturing Practices and GDP-Good Distribution Practices), and even 21 CFR part 11.

How did you incorporate these requirements into the platform?

That is the essential part of our compliance philosophy and I cannot stress it strongly enough. These requirements have been architected into the Allyfe platform. Every part, every module of the platform incorporates data security and privacy demands by design. We are convinced it is the only way to make compliance complete, but also dynamic and scalable. You can compare the Allyfe structure with a wall of Lego bricks. It is because every Lego brick is perfectly shaped that the wall is strong, perfectly straight and shock-resistant.

Allyfe is a European platform and complies with EU regulations. But it also complies with U.S. and international requirements. Does that mean that Allyfe can be used all over the world?

Absolutely. Clinical trials are developed across countries nowadays. It is important to assimilate GDPR requirements, but also, for instance, UK specificities (Allyfe is already used in the UK) and even California regulations, which are the strictest in the U.S.

Regulations change. GDPR is evolving, for instance. How does Allyfe cope with that?

Again, the fact that compliance has been architected into the platform makes it scalable and dynamic. Regulatory modifications propagate organically through the system,without additional coding.

Since you repeatedly mentioned Allyfe’s flexibility and modularity, are you implying that the platform compliance is guaranteed for oncological, cardiological,pediatric clinical trial, whatever its medical specialty is?

Absolutely.Of course, there is a common compliance base for all clinical trials so that the Allyfe can be used for all medical specialties. It is essential for research sites and CROs.

How does this universal, scalable, cross-specialty compliance benefit patients?

Compliance is a patient-centered effort: it is meant to protect patients’ rights. So caring about compliance is caring about patients, it is a mark of respect for patients. I think everyone, patients included, is fully aware now of the importance of privacy and security. When enrolling for a clinical trial, the patient has to be reassured that his/her personal data are perfectly protected,for instance. It contributes to his/her peace of mind.

How does it benefit investigators?

The Allyfe platform makes compliance management transparent, automated and immediate. No more time-consuming, labor-intensive archiving and visits logbook needed, for instance. All trial activities are systematically organized and recorded. Which also guarantees inspection readiness.

How about the sponsors?

Current trial hybrid approaches combine paper documents and unprotected electronic communications, multiplying uncontrolled process risks for sponsors. Allyfe digitalizes GCP requirements and mitigates these risks. Additionally, compliance is easily demonstrated in case of inspection by regulatory authorities.  

And the CROs?

Again,facilitating compliant process management is a time- and labor-saving solution for CROs too. They no longer have to coordinate information exchanges or data updates. They can focus their compliance efforts on process sections which demand constant attention.

Slightly provocative question to wrap it up: the first sentence of this article says that all state-of-the-art trial digital platforms have to be compliant. Then how is Allyfe unique in that respect?

Think again of the wall of bricks: because every brick is perfectly shaped, you can build any wall you want, as big as you want, as many times as you want, and it will remain strong and straight. Because compliance has been architected into every part,every module of the Allyfe platform by design, it can adapt to any trial context,to any regulatory evolution with minimal additional efforts and minimal additional risks. That is the force of scalability.