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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.
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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• Cardiovascular• Nephrology• Central Nervous
System– Psiquiatry– Neurology
• Pediatrics• Respiratory
• Gastroenterology• Oncology
– Breast Cancer– NSCLC
• Ophtalmology• Medical Devices• Geriatrics• Orthopedics• 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
• Restricted Area• Controlled
Temperature• Refrigerated Storage
DRUG STORAGE FACILITIES
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 MéxicoBlvd. Luis Donaldo Colosio N. 212, 3rd Floor
Colonia Arboledas de San JavierPachuca de Soto, Hidalgo
Mexico, 42084
Dr. Guillermo CalettiClinical Research Director
[email protected] Ph: +52(1)771-115-5314
Site Ph: +52-771-716-7269
