Start up and Study design

Any client requesting our services can rest assured of our complete dedication to the completion of their projects, from design and concept, through development, collation of results and potential publication, if required.

We offer end-to-end development solutions for your product or device, starting with early development advice, regulatory advice, meeting planning, study concept sheet, market access strategies, marketing applications and post-marketing activities.

We have an extensive database on all Spanish ethics committees, including all the necessary requirements, key personnel, sample study contract, and percentage of direct approvals by type of study.

We offer:

• Concept development & evaluation
• Protocol writing, editing and reviewing
• Case report form design
• Medical support & consultancy during study conduct
• Organization & conduct of Investigator’s meetings
• Site screening & selection
• Investigator screening & selection
• Submissions to IRBs & regulatory authorities
• Technical consultancy with regulatory authorities
• Trial files preparation
• Planning, budgeting & resourcing