"Building Connections to Improve Health"

 

Friday, April 27, 2018
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Clinical Operations 

"A great fit for smaller companies or those who prefer to leverage Excel's infrastructure" 

We free you to focus more on your discovery and science by: 

  • Managing your clinical trials from the beginning through study closeout.  We serve as the trial leader and work with the sponsor and the trial sites to manage to the  overall goals and requirements of the trial.  We will manage the trial by setting the objectives, scope, strategy, schedule, and ensuring that the trial is run in compliance with the protocol, GCP requirements and all regulatory bodies.
  • Managing your entire regulatory process -including writing protocols, investigator brochures, INDs, BLAs and NDAs.
  • Providing strategic direction to prepare for possible FDA and EMA audits.

  • Managing the vendor and contract process.

  • Developing and managing a comprehensive Quality Management Program.

  • Providing CRO Selection & Oversight (at Sponsor's request) – Excel handles all operational aspects of CRO bid/presentation, including drafting RFPs and study proposals. We ensure CRO is performing services according to task order and that all timelines and budgets are maintained. We also serve as the main point of contact for the Sponsor and will funnel enrollment, study status updates and relevant issues to sponsor Senior Management as needed.   We help make sure your study gets the attention it needs!

  • Clinical Trial Rescue - We find the issues, effectively manage solutions and restore quality to data and processes.

  • Quality Management - We will develop and manage a comprehensive Quality Management Program which would include Quality Assurance and Quality Control processes as well as a Corrective Action and Preventive Action (CAPA) Program.

We will ensure that all study processes are developed in compliance with GCP and regulatory requirements. Excel gives you peace of mind by helping you become or remain audit-ready!