ObelysQ
Excellence in Clinical Quality Assurance and Good Practices

Regulatory authorities continuously update stringent checks and requirements, especially related to data privacy and clinical trial practices, to ensure integrity, quality, and safety. However, companies, especially those operating on an international level, face difficulties in understanding this regulated landscape during their clinical trials in foreign regions. For example, American clients conducting trials in Europe may not be familiar with the intricate nuances of European clinical trials regulation (EU CTR) or local data privacy requirements. Conversely, European sponsors embarking on clinical trials in the US often lack experience dealing with inspections, despite their industry knowledge. This results in delays in their drug development projects. Turning to consultants who possess specific expertise and experience can help these companies move their projects forward by assisting them with the flexible management of their resources and focusing on specific aspects of projects for a set period of time.

As a recognized and dynamic consulting company providing high-level expertise and innovative tailored solutions to the pharmaceutical industry, ObelysQ aims to optimize the execution of clinical trials and overcome regulatory challenges. It is a nimble, renowned, and resourceful collective with a network of more than 30 consultants worldwide who maintain clinical caliber and assist companies of all sizes in following good clinical practices.

“Our current endeavor involves crafting a comprehensive program to prepare clients for regulatory inspections. We start with a gap analysis to identify critical inspection risks. Subsequently, we provide them with inspection readiness training, guide them through storyboard creation, and conduct mock inspections,” says Ludovic Moulin, managing director at ObelysQ.

The company’s role extends not only to alerting clients to new regulations but also to elucidating their implications. It helps them tailor these regulations to specific operational contexts, ensuring compliance and guiding companies to adopt effective approaches during inspections.

“Generally, clients require specific audits where they need specialized expertise, sometimes lacking resources or in-house expertise and having concerns about regulatory inspections. These client engagements can vary in scope, from single activities to more comprehensive audit programs spanning several months. With decades of experience in all types of audits and inspections, we are proud to conduct audits with a high impact,” says Arnaud Levain Chavanon, managing director at ObelysQ.

Overall, our services include good clinical practices (GCP) consulting, good pharmacovigilance practice (GVP) and GCP auditing, standard operating procedure (SOP) development, health authority inspection, gap analysis, EU CTR implementation support, data protection support, central review of audit reports, and corrective and preventive actions (CAPAs).

As an example, a biotechnology company in Switzerland engaged ObelysQ’s services to conduct a comprehensive audit of one of their clinical programs. The audit identified systemic issues extending beyond the site-level concerns to encompass sponsor-level aspects. Given the organization’s relatively modest size, it became evident that the oversight of vendor activities required optimization. One of ObelysQ’s key objectives was to collaborate with the client to develop a robust process for vendor oversight. The company identified areas within their QMS that warranted enhancement, characterized by certain weaknesses.

ObelysQ then embarked on a comprehensive gap analysis, encompassing a thorough review of the client’s entire QMS. It revised the SOPs in place and evaluated the practical implementation of these procedures within the context of two selected trials. Several months later, ObelysQ conducted a meticulous evaluation to ensure the accuracy, functionality, and effectiveness of the implemented measures.

Recognizing its expertise in quality assurance matters, the client requested it to serve as their dedicated outsourced quality assurance (QA) department. In this capacity, ObelysQ assumed the role of the primary point of contact for all quality-related concerns. It has established an ongoing retainer-based partnership, allowing it to actively participate in study team meetings and influential decision-making forums. This arrangement enabled it to provide real-time, proactive advice, enhancing the client’s operational efficiency and effectiveness. With a track record of client success stories like these, ObelysQ aims to leave its mark in the realm of clinical trials by providing solid GCP, GCLP, GVP, and data protection-related solutions. Through its network, the company can also provide GMP and GLP support.