Activa Cro Presentacion Jan 09

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My Company, Our Services & Our Key Factors for Success

My Company, Our Services & Our Key Factors for Success

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  • 1. Company Activa is a full-service Contract Research Organization (CRO) based in Buenos Aires, Argentina • Established in 2003 in Argentina • Economic growth rates doubling yearly • Operating in Chile since 2004 • First spanish Latam CRO Certified ISO 9001: 2000 (2006) • Operating in Uruguay since 2007 • Established in Mexico in 2008
  • 2. A local CRO with regional reach México Chile Uruguay Argentina
  • 3. Vision Through the principles of scientific excellence, flexibility and adaptability , our aim is to evolve into a “boutique” CRO, offering specialized services to our clients Mission Our endeavour is to satisfy our client requirements and expectations , working very close to them, in order to facilitate an efficient management of their projects.
  • 4. Activa was founded and is managed by senior professionals in Pharmaceutical, Medical device development and Regulatory affairs We offer combined decades of experience developing basic & clinical research programs
  • 5. Our aim is to be the leading Regional spanish speaking CRO in Latin America Our strenght lies in local and regional expertise, continous training of our staff and a robust Quality Assurance program
  • 6. Organizational Chart Board of Directors Regulatory Quality Mgnt. Business Administration Legal External Clinical Trial Affairs System Development & HHRR Advisor Auditors Department Department Department Department Department Pharmaco- Quality Mgnt. Project Quality Outsourcing Logistic & Administration System HHRR Managers vigilance Assurance Services Supply Chain & Finance Auditor Clinical Research Associates
  • 7. Organizational Chart Activa-CRO Headquarters Argentina - January 2009 CTM/CRAs Full Time, Biol, MD,s 13 CRA/CRA ass outsourced to Big Pharma 8 Consultants, MDs 17 Regulatory & QA 4 Business Development 3 Administration 5 Activa-CRO Chile 3 Activa-CRO Uruguay 2 Activa-CRO Mexico 4
  • 8. Our services Clinical research Our Scientific Advisory Committee (17 members at this time) with key investigators and opinion leaders , enables us to design studies for a wide range of therapeutic areas. Clinical Research services include: • Extensive PI Database • Patient identification, recruitment and retention • Investigator meeting organization and conduction • Monitoring Services. • Site Management. • Project Management
  • 9. Our services Clinical research (cont) • Study Design • Protocol/CRF Development • Local Project Coordination (includes sponsor representation for MOH & customs, contacts with PI, sites and vendors • Monitor Training • Supplies warehousing
  • 10. Our services Regulatory affairs • Advice on Regulatory procedures in countries of operation • Site Regulatory Files management • Ethics committee submissions • Management of IRB documents and operations • Local and Regional Regulatory Agency approvals • Import /Export licenses • Custom consultancy and management Our services include the preparation and submission of registration dossiers. We can recommend modifications in protocols in order to optimize the registration dossier, including evaluation of existing data.
  • 11. Our services Pharmacovigilance Local Representation • Receiving/Processing/Archiving adverse events in countries of operation • Ethics committee /IRB & MOH submissions • Ensure compliance with local & International requirements
  • 12. Our services Quality assurance In December 2006, ACTIVA was granted the ISO 9001:2000 Standard Quality Certification on “Control and surveillance on clinical research trial processes for the development of drugs, biological products and medical devices” This certification was issued by Bureau Veritas Certification and accredited by UKAS (Europe), ANAB (North America) and OAA (South America). Activa is the first regional CRO certificated in Management and Monitoring of Clinical Trials by ISO 9001:2000.
  • 13. Our services Training We offer in house training courses designed for clinical research personnel. Through our associated "Clinical Research Training Program" with academia (UBA, Fundación Margullies,etc) we train investigators, monitors, study coordinators and regulators with focus in the following areas: • GCP-ICH for investigators • Monitoring by therapeutic area • Individual Training Programs
  • 14. ACTIVA-CRO Therapeutic Areas • Dermatological • Endocrinology • Infectious Disease • Genitourinary • Metabolic • Psychiatry • Orphan Diseases • Cardiovascular • Oncology • Neurology • Hematology
  • 15. Advanced Development Overall Experience December 2003- Jan. 2009 Total No of Studies/Projects 36 No. of Studies/Projects Completed 16 No. of Studies/Projects Ongoing 20 No. of Studies/Projects in Start Up Phase 8 No. of Studies Projects currently active 12 No. of Active Sites 100+ No. of Patients 1000 + Phases of Studies/Projects Pre-Clinical to Phase IV Geographical Location of Clients USA/Germany/Switzerland/Spain/Israel /South Korea/Argentina Regulatory authorities to whom data is to ANMAT/FDA/EMEA/South Korea be submitted ANVISA/MOH Uruguay/Mexico/Chile No. of Therapeutic Areas 11 Agents on which studies being conducted Drugs/Biologics/Devices Type of Clients Small & Medium Biotech Small & Big Pharma Devices Industry
  • 16. Our key factors for success • We recognize the need for shortened R&D cycles and reduced costs for testing new products. • We contact only distinguished and experienced clinical investigators with combined experience and extensive databases for patient enrollment. • Directors have had hands on experience in all aspects of clinical development • Our experienced staff is focused on patient safety , strictly following ICH-GCP standards.
  • 17. Why Latinamerica? Population: Health System: • Concentration of medical care in big cities • Large patient population in almost all type of • Public, Private, Community and Union therapeutic indications Hospitals • Treatment of native patients with similar • Modern central laboratory/imaging centers ethnic characteristics • High level in telecommunications infrastructure • Excellent patient motivation Sites: • Experienced Investigators • Established, qualified investigators Regulatory: • Motivated and enthusiastic investigators • Well established regulatory environments • Accelerated patient recruitment rates • Investigators with excellent retention of • Acceptable regulatory approval timelines patients • 100% GCP-ICH compliance • High quality data Market: • Reduced operational costs Geographical-Cultural: • Fewer competitive studies • Inversion of seasons • Potential commercial market for new • Similar time zones as the United States products • Prevalent European immigration • Understanding of English is prevalent