Whether you are launching a new clinical program, facing a specific compliance challenge, or navigating a resource gap, ObelysQ provides pragmatic, hands-on GCP consulting tailored to your needs. We help sponsors identify and mitigate risks, build fit-for-purpose quality frameworks, and maintain oversight of clinical activities in line with regulatory expectations. Our flexible engagement models—on-site, remote, or hybrid—ensure you receive the right level of support at the right time, without unnecessary overhead.
We needed ad-hoc access to a GCP expert to support our Head of Quality, whose background was primarily GMP. ObelysQ stepped in as our GCP Quality Lead, bridged the expertise gap, and ensured we met our sponsor obligations with confidence.
CSO, Small Swiss Biotech (University Spin-off)
In-House GCP Expert (Fractional or Interim Support)
Together with you, ObelysQ evaluates the level of effort required for your project. Whether you need two days per week, a few days per month, or short-term intensive support, we ensure consistent access to a senior GCP expert who integrates seamlessly with your team and enables progress without disruption.
Remote & On-Demand Consulting
Sometimes you need rapid validation, expert challenge, or guidance on a specific issue rather than a permanent on-site presence. ObelysQ provides responsive, remote GCP consulting to review documents, advise on risk decisions, and support your teams when and where needed.
We do not believe in one-size-fits-all solutions. Working with ObelysQ means access not just to an individual consultant, but to a team of experienced GCP professionals who collaborate internally to bring collective expertise to your challenges—particularly valuable when facing bottlenecks or complex decisions.
Case Study
Overview: ObelysQ acted as the Head of Quality Assurance for a small biotech sponsor preparing to initiate clinical activities.
Challenge: The company needed to build a GCP-compliant Quality Management System from scratch while operating under significant time and resource constraints.
Results: ObelysQ implemented a tailored, high-level QMS focused on core sponsor obligations and regulatory expectations. The pragmatic system enabled compliant clinical operations and had a positive impact during due diligence activities, strengthening the company’s credibility with partners.
Overview: ObelysQ was engaged by a Swedish biotech to replace a previous QA consultant to revamp and finalize their QMS.
Challenge: The existing QMS was overly complex, poorly aligned with operational reality, and insufficiently embedded across departments. Compliance issues and resistance from teams highlighted the need for a reset.
Results: ObelysQ conducted targeted interviews with functional leads to understand operational needs and redesigned the QMS accordingly. SOP lengths were reduced by approximately 50%, adoption increased significantly, deviations decreased, and the updated QMS successfully passed a sponsor inspection by EMA.
Overview: ObelysQ was engaged to establish and manage a GCP audit program for a sponsor conducting a Phase III trial.
Challenge: The GCP QA role had been vacant for an extended period, resulting in the absence of audits during a critical phase of recruitment.
Results: ObelysQ designed and implemented a risk-based three-year GCP audit plan, ensuring appropriate quality oversight of investigator sites, vendors, and sponsor processes. The program restored ongoing trial governance.
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