Clinical Studies for Investigational Medicinal Products (IMP)
Sourcia supports drug development for your investigational medicinal product (IMP) in every clinical stage with a strong focus on Phase II-IV clinical trials. Sourcia has extensive experience across multiple therapeutic areas and offers professional and experienced staff to the needs of your development process.
Sourcia can assist within the entire drug development process by providing the following services:
- Clinical Strategy Development: by documenting clinical and scientific performance and supporting data for competitors and recent filings in the related area(s); by identifying the right regulatory guidelines or rulings that will impact expectations for upcoming trials; and by evaluating various trial design options and prioritising the options by comparing the duration and the costs of the development programs.
- Study startup & Regulatory Affairs Management: by identifying startup risks and contingencies, preparing study related documents and submissions to the Competent Authority and Ethics Committee, and conducting the site contracting;
- Recruitment & Retention: by performing site training during site initiation visits and monitor & manage the roles and responsibilities throughout the clinical study;
- Project Management: by assuring study and protocol compliance, by managing budgets & timelines, communication & mitigation plans, performing risk assessments, and managing collaborations with third parties;
- Monitoring: by performing and monitoring site initiation visits, interim monitoring visits, close out visits, and IMP accountability. Monitors can be provided in every country throughout Europe;
- Electronic Trial Master File (eTMF) setup and Management: by setting up and maintaining eTMFs, measure multiple quality controls, preparing for archiving, and giving access to SharePoint;
- Safety Management: by setting up safety management plans, handle safety reporting, reconciliate SAEs, perform regulatory reporting, setting up safety databases and performing annual safety reporting;
- Quality Management: by performing trainings, audits and inspections.
- Market approval: by supporting the scientific and competent regulatory process to evaluate the safety and effectiveness of your development program.
- Post-marketing support: by supporting post-market surveillance studies.
Your clinical study at Sourcia will be conducted to the highest quality and ethical standards.
Sourcia's study approach results in the following benefits for your trial:
- Focus: the project model will be tailored to your actual needs;
- Quality: the best people will be located in the right positions;
- Efficiency: activities will be combined;
- Dedication: collaboration between the right sized companies with matching cultures;
- Transparency: project status tracked real time;
- Cost savings: building in efficiencies for Project Management.