Services

Project Management

Our approach to Project Management incorporates our core competencies: adaptability, flexibility, proactivity and quality at the best possible price.

Full Coverage

Whether it's a First In Human or a multi-site Proof Of Concept program our Project Management vision covers the entire scope of the study from service provider qualification through CSR (Clinical Study Report) submission ensuring that all components integrate seamlessly with the main objective:
meeting YOUR expectations.

Important Considerations

- Proactive and flexible approach

- Assessment of Sponsor resources, objectives and critical development milestones

- Clear communication of study objectives and requirements

- Ability to communicate in multiple languages, mitigate cultural/linguistic differences and manage time zone differences

FIH through POC Experience

- Service provider qualification and management

- Feasibility assessment

- Contract development, negotiation, proposal analysis and financial planning

- Project Management Plan preparation

- Coordination of site start-up activities and logistics

- Selection and management of specialized service providers:

· Regulatory submissions

· Data Management

· PK/PD analysis

· Protocol and Medical writing

· Bioanalytical Services