Introduction to I.D.E.A., Ltd


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I.D.E.A. Ltd. supplies Legal Representative Services to sponsors of clinical trials and orphan drug designations (ODDs) who do not have business premises in the EU.

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Introduction to I.D.E.A., Ltd

  1. 1. Providing Legal Representation for Clinical Trials in the EU
  2. 2. Overview • I.D.E.A., Ltd. is a privately-held professional services company that fulfils the requirement for Legal Representation specified in Article 19 of the Clinical Trials Directive − Compliance required by Directive 2001/20/EC, Art.19, for non-EU Sponsors
  3. 3. History of I.D.E.A. • Founded in 2006 − Satellite of HCR, a full-service, global CRO • Specialist Legal Representative service for non-EU clinical trial sponsors • Hold Orphan Drug Designations (ODD’s) for non-EU companies
  4. 4. History of I.D.E.A. • Preferred provider for small/medium CRO’s − Stabilized pricing, accurate budgeting − Continuity across multiple programs/projects • Strong repeat business − Excellent reputation supports word of mouth referrals • Fully independent − Neutral
  5. 5. Why Conduct Ph I-IV Clinical Trials in the EU? • 28 member states in the EU − Number of member states will increase • Population = 510 million − Ethnically diverse − Demographic distribution similar to US • Robust healthcare infrastructure − Study-naïve, compliant patient population
  6. 6. Summary of Requirements • Trial can not be approved by Regulatory or Ethics authorities without EU Legal Representative • Compliance required by Directive 2001/20/EC, Art.19, for non-EU Sponsors − Takes on the position of the Sponsor in the EU to ensure compliance to regulations and GxP − Point-of-contact for EU authorities − Applicable in all EU member states
  7. 7. Summary of Requirements • Must understand EU clinical trial legislation and the regulatory environment • May have different legal representatives for each trial or one for all EU trials • A Sponsor who wants to conduct an EU clinical trial but does not have an EU office...  Must have an EU Legal Representative
  8. 8. Management Team Dr Francisco Harrison, Chairman, Germany ▫ Over 30 years experience in management and operation of clinical trials including as Chief Investigator for multi-centre trials ▫ Founder & Board level management of several diverse companies ▫ Founded Harrison Clinical Research in 1987 (now VP for SynteractHCR) Tamsyn Frost, Director, UK ▫ Over 6 years experience in Regulatory Affairs - specialising in Quality/Regulatory interface, Clinical Trials and Orphan Drug Development ▫ Experience in quality management, project coordination and business development. Background in applied biology and reproductive toxicology ▫ Currently completing the TOPRA MSc in Regulatory Affairs
  9. 9. IDEA Ltd: Contact Information Ta m s y n F r o s t Director 4th Floor, 1 Kingdom St. Paddington London W2 6BD United Kingdom Francisco Harrison Chairman Tel: +44 (0)1223 402 666 Fax: +44 (0)1223 413 689