Activities to your needs
With its strong partners in clinical research and drug development I.D.E.A. Ltd. can offer a focused yet flexible package of services for non-European companies, which include Regulatory, Pharmacovigilance, Medical Writing and other Medical services, and assistance with Clinical Trial Supplies Management.
The sponsor may choose from our range of service options to create a customised package.
Legal Representation
Legal Representation of the Sponsor within the EU as defined by Directive 2001/20/EC Article 19 which includes:
- Coordination with Local authorities for Sponsor and investigator site inspections
- Ensuring International Conference of Harmonisation (ICH), Good Clinical Practice (GCP) compliance
- Regular updates on relevant changes to EU legislation
- Liaison with the Ethics Committee and Competent Authority for clinical trial authorisation and amendment submissions
- Co-signing contracts between Sponsor and Investigator and Site (as required by some EU Authorities)
Manufacturing and Shipping Support Services
- Preparation of the qualified person responsible materials and identification of a QP (CMC)
- Import of clinical trial supply materials
Pharmacovigilance Services
- Acting as "Responsible Person" (RP PVG) in the EU for Licensed/Marketed Products
- EudraVigilance registration
(Responsible Person (QP PVG) in the EU) - Safety monitoring and reporting
- Adverse Event Reporting to the Relevant Authorities, including:
- Documentation of Suspected Adverse Events
- Reporting of Suspected Unexpected Serious Adverse Reactions
- Initiating safety measures promptly
- Submission of Suspected Unexpected Serious Adverse Reactions (SUSAR's) to European Medicines Evaluation Agency and its Database
- Adverse Event follow-up including urgent safety measures, if necessary
Regulatory Services
- Preparation of clinical trial authorisation applications and substantial amendments
- Organisation of insurance for the trial (Sponsor's Liability and local insurance for trial subjects)
- Expert advice on EU issues
- Review of clinical protocols/study reports
- Establishing Scientific Advisory Boards