Quality is the foundation of successful clinical development and must be embedded from strategy through execution. A robust Quality Management System (QMS) provides the structured framework needed to ensure regulatory compliance, manage risk, and maintain oversight across all clinical activities. By defining governance, responsibilities, and controlled quality processes, a QMS supports inspection readiness, informed decision-making, and consistent execution throughout the clinical trial lifecycle. Beyond compliance, a strong QMS protects patient safety and data integrity while enabling operational efficiency and sustainable clinical development.
We knew we had to work on our QMS but we had limited time and budget. ObelysQ helped taking the pressure off our function heads and project-managed the inception of our system without the need for fancy tools.
Head of Clinical operations, Swiss Biotech
Clear, well-defined processes are essential to turning quality principles into day-to-day clinical operations. Standard Operating Procedures (SOPs) translate regulatory requirements and QMS expectations into practical, actionable guidance that ensures consistency across teams, sites, and vendors. Well-designed SOPs support effective training, alignment, and accountability, while reducing variability and operational risk. When SOPs are scalable and fit for purpose, they become powerful tools that enhance compliance, inspection readiness, and confidence in clinical trial execution.
Case Study
Overview: A biotech startup transitioning from preclinical to clinical development recognized the need to establish a robust Quality Management System (QMS) to support its first-in-human trial and future regulatory submissions. They turned to ObelysQ for expert guidance in designing and implementing a fit-for-purpose QMS from the ground up
Challenge: The company had minimal quality infrastructure and limited experience with GxP requirements. Without a formalized QMS, they risked compliance issues, operational inefficiencies, and delays in trial initiation. They needed a scalable, inspection-ready system tailored to their size and stage of development — but built to grow with the company.
Results: ObelysQ designed and implemented a pragmatic, risk-based QMS, including core SOPs, document management systems, training programs, and vendor oversight processes. The system was tailored to meet current regulatory expectations while allowing flexibility for future expansion.
Overview: Biotech company with headquarters in Asia and strong presence in the USA was working under two separate QMS. The desire to combine both QMS was officialized in a corporate objective. Support was requested to help combine SOPs.
Challenge: The SOPs to be combined were not written in the same format and same language. Cultural differences were to be taken into consideration. Process ownership was difficult to identify as there was competition between regions.
Results: ObelysQ delivered a series of 20+ SOPs that supported the integration of both QMS. Allocating this task to an external party reduced internal tensions.
Overview: A private European clinic network needed to set-up SOPs to support their endeavor to increase their participation in industry-sponsored trials, but also manage their in-house investigator initiated trials.
Challenge: Starting from scratch required ensuring that the involved team members understood the rationale for the implementation of the SOPs and how it was important for them to adhere to these processes. There was no internal clinical QA resources.
Results: Within a four-month period, ObelysQ delivered the SOPs required by the clinic, helping them raising quality and compliance levels. This set of SOP was built in a way that they could also support activities conducted at other affiliated clinics.
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