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GENERAL CLINICAL RESEARCH CENTER
Clinical Research Investment
• One third of Clinical Trials sponsored by
  Major Pharma companies have been
  conducted outside USA.
• Cost savings conducting Clinical Trials in
  India and South America

                            Source: NEJM Feb 2009
Clinical Research in
            Latinamerica
• Large subject population available
• Main countries: Mexico, Brazil, Argentina.
• Advantages:
  – Qualified Investigators
  – Established regulations
  – Well understanding of ICH/GCP guidelines

                 Source: Applied Clinical Trials, May 2003
Clinical Research in Mexico

• 2004 – 300 Clinical Trials were conducted
  in Mexico in 20 Therapeutic areas and 1000
  Institutions across the country.


                           Source: AMIIF
Hidalgo
      • Capital – Pachuca.
      • 60 miles away from
        Mexico City.
      • 2 333 884 inhabitants.
      • Well developed Health
        infrastructure.
      • Private Health Institutions
        and Independent Ethics
        Committee.
• 58% of inhabitants do not have
  affiliation to Health Care
  Government Institutions
• Näive patients in Main therapeutic
  areas
• Medical Doctors familiarized with
  ICH/GCP
• Institutional Health Care facilities –
  IMSS, ISSSTE, SSa.
Our Clinical Research Site
• Located in Pachuca, Hidalgo.
• Hospital Intermedica es the newest Health
  Care facility.
• We are the best equiped Hospital
  – MRI
  – Advanced CAT Scan technology
  – Advanced Laparoscopic equipment
Main Therapeutic Areas
•   Diabetes Mellitus   • Gastroenterology
•   Cardiovascular      • Oncology
•   Nephrology              – Breast Cancer
•   Central Nervous         – NSCLC
    System              •   Ophtalmology
    – Psiquiatry        •   Medical Devices
    – Neurology         •   Geriatrics
• Pediatrics            •   Orthopedics
• Respiratory           •   Gyn & Obs
HOSPITAL FACILITIES
LOBBY
OPERATING ROOM
NURSE STATION
HOSPITAL FLOOR
HOSPITAL STAIRS
HEMODIALISYS
HEMODIALISYS
RESEARCH CENTER FACILITIES
RECEPTION
MEDICAL OFFICES HALL
DOCTOR OFFICE
EXPLORATORY ROOM
OPHTALMOLOGY
DENSITOMETRY
MAMOGRAPHY
PEDIATRICS
ARCHIVING FACILITIES
DRUG STORAGE
  FACILITIES


• Restricted Area
• Controlled
  Temperature
• Refrigerated Storage
SEPARATE SAMPLING AREA
Our Strengths
• Dedicated facilities
• Staff trained in ICH / GCPs
• Strong health care delivery system
• In deep ICF discussion with patients.
• Patients with Untreated or undertreated
  health conditions
• KOL as investigators
Our Advantages
•   Näive patients
•   Placebo use allowed when justified
•   On time recruitment.
•   Dedicated Call Center for Patient Recruitment.
•   Best Quality in Source Documentation.
•   Deliverables within agreed Study Budget.
•   e-CRF & IVRS experience
•   Fast IEC submission / approval (two weeks)
RECRUITMENT CALL
     CENTER
• Dedicated facilities for
  patient recruitment.

• Staff trained in ICH/GCP
  and specific study
  protocol.

• Individual study
  questionnaire designed to
  be resolved in a call.
• Toll free number
  available across
  Mexico
• Medical advisor
  available to help in
  patient doubts.
• Service available
  for outsourcing.
Why a Call Center?
• Full time dedicated people for patient
  recruitment.
Call Center tasks
• Weekly call inventory
  per clinical trial.
• PI contact info is
  provided to each
  interested person.
• Weekly calls list with
  patient contact info
  provided to PI.
Recruitment Strategies
• Graphic Design (Advertising, Flyers,
  Posters, Clinical Brochures).
• Dedicated Call Center.
• Individual Recruiter per site (depends on
  specific Therapeutic Area).
  – Hospital Records review.
  – Patient Referals.
Research Center Contact Info
  Centro de Investigación Clínica de México
  Blvd. Luis Donaldo Colosio N. 212, 3rd Floor
        Colonia Arboledas de San Javier
           Pachuca de Soto, Hidalgo
                Mexico, 42084

                                          Dr. Guillermo Caletti
                                    Clinical Research Director
                           guillermo.caletti@accessnet.com.mx
                                  Cel Ph: +52(1)771-115-5314
                                   Site Ph: +52-771-716-7269

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Clinical Research Center Facilities

  • 2. Clinical Research Investment • One third of Clinical Trials sponsored by Major Pharma companies have been conducted outside USA. • Cost savings conducting Clinical Trials in India and South America Source: NEJM Feb 2009
  • 3. Clinical Research in Latinamerica • Large subject population available • Main countries: Mexico, Brazil, Argentina. • Advantages: – Qualified Investigators – Established regulations – Well understanding of ICH/GCP guidelines Source: Applied Clinical Trials, May 2003
  • 4. Clinical Research in Mexico • 2004 – 300 Clinical Trials were conducted in Mexico in 20 Therapeutic areas and 1000 Institutions across the country. Source: AMIIF
  • 5. Hidalgo • Capital – Pachuca. • 60 miles away from Mexico City. • 2 333 884 inhabitants. • Well developed Health infrastructure. • Private Health Institutions and Independent Ethics Committee.
  • 6. • 58% of inhabitants do not have affiliation to Health Care Government Institutions • Näive patients in Main therapeutic areas • Medical Doctors familiarized with ICH/GCP • Institutional Health Care facilities – IMSS, ISSSTE, SSa.
  • 7. Our Clinical Research Site • Located in Pachuca, Hidalgo. • Hospital Intermedica es the newest Health Care facility. • We are the best equiped Hospital – MRI – Advanced CAT Scan technology – Advanced Laparoscopic equipment
  • 8. Main Therapeutic Areas • Diabetes Mellitus • Gastroenterology • Cardiovascular • Oncology • Nephrology – Breast Cancer • Central Nervous – NSCLC System • Ophtalmology – Psiquiatry • Medical Devices – Neurology • Geriatrics • Pediatrics • Orthopedics • Respiratory • Gyn & Obs
  • 10. LOBBY
  • 19.
  • 28. DRUG STORAGE FACILITIES • Restricted Area • Controlled Temperature • Refrigerated Storage
  • 30. Our Strengths • Dedicated facilities • Staff trained in ICH / GCPs • Strong health care delivery system • In deep ICF discussion with patients. • Patients with Untreated or undertreated health conditions • KOL as investigators
  • 31. Our Advantages • Näive patients • Placebo use allowed when justified • On time recruitment. • Dedicated Call Center for Patient Recruitment. • Best Quality in Source Documentation. • Deliverables within agreed Study Budget. • e-CRF & IVRS experience • Fast IEC submission / approval (two weeks)
  • 33. • Dedicated facilities for patient recruitment. • Staff trained in ICH/GCP and specific study protocol. • Individual study questionnaire designed to be resolved in a call.
  • 34. • Toll free number available across Mexico • Medical advisor available to help in patient doubts. • Service available for outsourcing.
  • 35. Why a Call Center? • Full time dedicated people for patient recruitment.
  • 36. Call Center tasks • Weekly call inventory per clinical trial. • PI contact info is provided to each interested person. • Weekly calls list with patient contact info provided to PI.
  • 37. Recruitment Strategies • Graphic Design (Advertising, Flyers, Posters, Clinical Brochures). • Dedicated Call Center. • Individual Recruiter per site (depends on specific Therapeutic Area). – Hospital Records review. – Patient Referals.
  • 38. Research Center Contact Info Centro de Investigación Clínica de México Blvd. Luis Donaldo Colosio N. 212, 3rd Floor Colonia Arboledas de San Javier Pachuca de Soto, Hidalgo Mexico, 42084 Dr. Guillermo Caletti Clinical Research Director guillermo.caletti@accessnet.com.mx Cel Ph: +52(1)771-115-5314 Site Ph: +52-771-716-7269