This is the presentation of our facilities as well as therapeutic areas we are able to manage. 14 years ofcumulated experience in Clinical Research field in Mexico and Latin America make us your best choice in Clinical Research centres in Mexico.
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
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.