Summary
A Spanish clinical research organization (operating in Spain, Italy and Portugal) offers outsourcing services for the pharma industry, biotech companies, medical device manufacturers, the food industry and other CROs for developing Phase I to Phase IV clinical trials, medical devices, observational and food studies. The company seeks outsourcing or commercial agency agreement, and/or subcontracting.
Description
The company started their activity in 2007 as a clinical contract research organization (CRO) and has offices in Spain, Italy and Portugal.
The corporation provides outsourcing services for research and investigation with drugs, medical devices, cosmetics and functional food.
The services offered by this company are as follows:
• CRO services: Definition, planning and design of medical studies, medical writing, site selection, regulatory and EC submissions (which include the preparation of documentation adapted to the local law, obtaining the necessary approvals by the IECs/IRBs (independent ethics committee / institutional review boards) and regulatory international to national authorities), contract negotiation, monitoring and follow-up of clinical studies, data management of the files generated during the study, biostatistical analysis and long term archive. They provide these services in Spain, Italy and Portugal and through AICROS (Association of International CROs).
• Pharma Consulting services-Registrations: Preparation of dossier for the registration of pharmaceutical products and medical devices.
• Pharma Consulting services-Medical affairs: Medical writing, market access, medical education and medical advertising.
• Pharmacovigilance: The organization is also able to create a specific safety system to be followed to reduce the risks and increase the benefits of investigating medicinal products throughout its lifecycle, both in the clinical phases and in the marketing phase. They also offer local and European representation services for pharmacovigilance. These services include the creation of a specific plan to be followed in each study that is adapted to the good pharmacovigilance practice guidelines under the EU legal framework.
• Clinical Auditing services: Investigational site GCP Audit, GVP Audit, support for inspections.
• Distribution Warehouse: Distribution of medicinal products from their warehouse in Spain.
The company is interested in building alliances for multi-country studies and exchange of opportunities so the company is looking for subcontracting, outsourcing and/or commercial agency agreements, with international companies interested in full range of outsourcing services to sponsors and other CROs abroad seeking alliances for multi-country trials.
