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Expertise

Clinical Trial Operations

Partner your way, we are your single contact for all activities towards your clinical success.

Identifying the right outsourcing partners for your clinical studies is not easy. Managing and coordinating multi-stakeholders in addition to your in-house professionals adds a layer of complexity to clinical research. We work as your single contact point to coordinate with all your clinical development partners to meet regulatory requirements and to ensure commercial success.

We complement and support your team for clinical study management at every step, overseeing the planning, design, submission, and execution of your clinical studies from its beginning to its end:

  • Study Design: Design and review patient-centric protocol with endpoints. Align the study with overall development goals taking into account all stakeholders.
  • Study Preparation: Optimize the timeline to first-patient-in. Advice for patient recruitment and network building
  • Study Submission: Prepare and submit clinical trial application to secure study approval.
  • Study Conduct & Coordination: Optimize interaction between all stakeholders and ensure data collection and quality supporting your endpoints.
  • Clinical Safety: Build a scalable safety system, oversee and manage the clinical risk assessment.
  • Regulatory Maintainance: Maintain regulatory dossier to ensure compliance.

Why choose VCLS?

  • Our deep understanding and discerning power regarding the regulatory requirements and their implementation in different bodies and regions brings unique insights to your project.
  • We have a global reach and the capability to manage the study long-term.
  • Our therapeutic expertise, product knowledge and know-how in orphan diseases, oncology empower us for today’s complex studies.

Our Approach

  • Seasoned Clinical Project Managers– the cornerstone of your clinical study team.
  • In-house core Experts – align the study with your overall objectives, and drive trial conduct.
  • The network of excellence across other critical functions – the ability to leverage the most suitable resources for your program.

 

Emergency Response Getting Ahead of The Competitors

I really enjoy working with the VCLS team because I know that they always have things under control. They are prompt to escalate any issues and implement team decisions quickly. They always offer their expertise and collaborate well with all parties (sites, CRAs, sponsor, etc) to find mutually agreeable resolutions to keep projects moving forward. And they’re all really nice and funny, so every meeting is engaging.

Director of Clinical Operations, US-based emerging biotech focusing on rare disease

VCLS Expertise