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EDC PHARMA SERVICES

EDC PHARMA SERVICES. Capacity . Expertise . Solutions . Technology. Our Mission. To improve science and technology for a better and healthier tomorrow. Quick Facts about EDC. US based Capabilities in 54 countries Breadth of biopharmaceutical services from Phase 1-1V Global Presence

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EDC PHARMA SERVICES

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  1. EDC PHARMA SERVICES Capacity . Expertise . Solutions . Technology

  2. Our Mission To improve science and technology for a better and healthier tomorrow

  3. Quick Facts about EDC • US based • Capabilities in 54 countries • Breadth of biopharmaceutical services from Phase 1-1V • Global Presence • Recent global partnerships

  4. Our Company • Premier service provider to the biotechnology, pharmaceutical and medical device company

  5. Capacity.Expertise.Technology. Solutions • Our management team has over 200 years combined experience supporting clinical development programs • Ability, infrastructure, resources and capabilities to conduct clinical trials on all seven continents

  6. Our Relationship • EDC Pharma Services is committed to: • Shared vision going into a project • Formal mechanism for providing feedback throughout the course of the relationship • Senior managementinput,involvement and support • Tools,templates,and systems for documenting client expectations prior toproject launch • Established issueescalation and resolution policy • Frequentface-to-face meetings • A strong service culture

  7. Clinical Trial Services Expertise • EDC Pharma Services provides a comprehensive array of clinical trial services to the pharmaceutical, biotechnology and medical device industry. Our global capabilities include: • Clinical Project Management • Clinical Trial Monitoring • Feasibility Studies • Investigator recruitment • Investigator meeting planning and preparation

  8. Clinical Trial Services • Regulatory document preparation and collection • Site personnel training • Site contract and budget negotiations • Study command center • Clinical Biostatistics • Clinical Quality Assurance • Clinical Data Management • US and Global Regulatory Affairs • Medical Monitoring and Safety Surveillance • Medical Writing

  9. Clinical Trial Services • Bioavailability studies • Bioequivalence studies • Drug interaction studies • Steady state studies • Food Interaction studies • Single and Multi dose studies • Bioequivalence assessment of generic dosage form

  10. Worldwide Monitoring Force • A solid and therapeutic aligned monitoring force of over 150 monitors on seven continents • All monitors have 5 or more year clinical trial monitoring experience

  11. Contact Us • Global Capacity • Global Expertise • Global Solutions • Global Technology • The CRO You Can Count On • www.edcpharma.com • Cproudlock@edccpharma.com • Tel: 732-516-8228

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