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Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach

Clinical Operations

Clinical operations are the backbone of a successful trial, guaranteeing studies are conducted efficiently, on time, and within budget while living up to the highest standards of quality and compliance. It entails meticulous planning, execution, and management of the trails, including site or vendor selection, patient recruitment, data collection, and data management. 

 

By leveraging our highly experienced network, you can provide your therapeutic application and the patient population who needs it with the best chance of success. Our experts have bring extensive experience in optimizing clinical operations, providing strategic guidance and hands-on support to streamline processes, strategically manage resources, and overcome challenges.

Strategic Resource Planning

 

Program/Project Management

 

Protocol Development & Study Design

 

Site Selection & Management

 

Trail Monitoring

 Clinical Trial Management System (CTMS) Implementation

 

Regulatory Compliance

 

Documentation & Record Keeping

Electronic Trial Master Files (eTMF) Implementation 

Vendor Selection & Oversight

Contract Research Organizations (CROs)

Contract Manufacturing Organizations (CMOs)/Contract Development & Manufacturing Organizations (CDMOs)

Academic Research Organizations (AROs)

Contract Labs

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San Diego, CA                                                                                                                                info@Totellinc.com

Related Topics

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Regulatory Affairs

CMC & Product Development

CRO/Vendor Selection & Oversight

Quality Control & Quality Assurance

Biometrics

Clinical IT

Medical Affairs

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