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EDC PHARMA SERVICES Capacity. Expertise. Solutions. Technology.

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Presentation on theme: "EDC PHARMA SERVICES Capacity. Expertise. Solutions. Technology."— Presentation transcript:

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 US based Capabilities in 54 countries Capabilities in 54 countries Breadth of biopharmaceutical services from Phase 1-1V Breadth of biopharmaceutical services from Phase 1-1V Global Presence Global Presence Recent global partnerships Recent global partnerships US based US based Capabilities in 54 countries Capabilities in 54 countries Breadth of biopharmaceutical services from Phase 1-1V Breadth of biopharmaceutical services from Phase 1-1V Global Presence Global Presence Recent global partnerships Recent global partnerships

4 Our Company Premier service provider to the biotechnology, pharmaceutical and medical device 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 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 Ability, infrastructure, resources and capabilities to conduct clinical trials on all seven continents Our management team has over 200 years combined experience supporting clinical development programs 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 Ability, infrastructure, resources and capabilities to conduct clinical trials on all seven continents

6 Our Relationship EDC Pharma Services is committed to: EDC Pharma Services is committed to: Shared vision going into a project Shared vision going into a project Formal mechanism for providing feedback throughout the course of the relationship Formal mechanism for providing feedback throughout the course of the relationship Senior management input,involvement and support Senior management input,involvement and support Tools,templates,and systems for documenting client expectations prior to project launch Tools,templates,and systems for documenting client expectations prior to project launch Established issue escalation and resolution policy Established issue escalation and resolution policy Frequent face-to-face meetings Frequent face-to-face meetings A strong service culture A strong service culture EDC Pharma Services is committed to: EDC Pharma Services is committed to: Shared vision going into a project Shared vision going into a project Formal mechanism for providing feedback throughout the course of the relationship Formal mechanism for providing feedback throughout the course of the relationship Senior management input,involvement and support Senior management input,involvement and support Tools,templates,and systems for documenting client expectations prior to project launch Tools,templates,and systems for documenting client expectations prior to project launch Established issue escalation and resolution policy Established issue escalation and resolution policy Frequent face-to-face meetings Frequent face-to-face meetings A strong service culture 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: 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 Project Management Clinical Trial Monitoring Clinical Trial Monitoring Feasibility Studies Feasibility Studies Investigator recruitment Investigator recruitment Investigator meeting planning and preparation Investigator meeting planning and preparation EDC Pharma Services provides a comprehensive array of clinical trial services to the pharmaceutical, biotechnology and medical device industry. Our global capabilities include: 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 Project Management Clinical Trial Monitoring Clinical Trial Monitoring Feasibility Studies Feasibility Studies Investigator recruitment Investigator recruitment Investigator meeting planning and preparation Investigator meeting planning and preparation

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

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

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

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


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