presentation clinical research centre of mexico

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

guillermo.caletti@accessnet.com.mxCel Ph: +52(1)771-115-5314

Site Ph: +52-771-716-7269