Laboratorio Hidalgo provides Clinical Laboratory Services related to the development of Clinical Trials: reliable results and effective logistics.

The proximity to investigators sites and to domestic and international airports allows the arrival of the samples in less than 24 hours, thus ensuring the integrity of the specimens. Communication with the investigators in their own language together with knowledge of the local needs ensures a prompt and cost effective response. All this plus the fastest turn around time makes the choice of our laboratory a real benefit to you. Combining over 40 years of Laboratory experience, with state of the art technology, efficient logistic and rigorous quality system has led us to be internationally competitive.

Laboratorio Hidalgo has developed strategic alliances with prestigious clinical trial laboratories in Europe and North America. This has allowed us to participate in multicenter global studies where the essential requirement is the outstanding service.

Comprehensive monitoring of Clinical Trials is provided by qualified study coordinators to ensure compliance with the protocol, Good Clinical Practices and SOPs from study start to closure.

Clinical Trial Set Up

• Team dedicated to the set up of the study
• Scientific support
• Evaluation of logistics and transport issues
• Development of documents & supplies
• Data Base set up & validations
• Training sessions for nurses, phlebotomysts or study coordinators

Clinical Trial Development

• Team dedicated to the development of the study
• Close contact with the investigators
• Scientific support to the sites
• Transport coordination
• Periodic data base cleaning

Clinical Trial Closure

• Final data base cleaning and closure
• Electronic Data Transfer
• Archiving of all source documents
• Final report with statistics

Strict fulfillment of the local and IATA transport regulations completes our logistics services, to give you the support you need for a successful trial.

New requirements for developing clinical trials have led to the market to be more demanding in the assurance of reliable data. Our IT Department supports the clinical trial division ensuring the compliance with the new regulations and providing new and cost- efficient technologies. Our IT Department provides:

Software for customized lab reports:

• Demographic Data
• Units / reference ranges and specific flags
• Language
• Blinded / Hidden and Reflex results

Electronic Data Transfer:

• Customizable format file and frequency

Software designed to:

• Develop and control kits & supplies
• Samples reception and control

Special features:

• Metrics to assess the efficacy of the each step in the process
• Other reports requested by the client (management reports)

Laboratorio Hidalgo meets the requirements of 21CFR part 11 in all the stages of the process where electronic records and signatures are involved.

Laboratorio Hidalgo bases its processes and workflow on a Quality Management System. Laboratorio Hidalgo is ISO 9001:2000-certified by TDCV-Reihnland/Berlin-Brandenburg and ISO 15189 accredited (Medical laboratories: particular requirements for quality and competence). Through constant monitoring, with a focus on continual improvement, Laboratorio Hidalgo ensures that clients are satisfied with the service they receive.

Laboratorio Hidalgo is committed to providing the highest quality service to its clients in full compliance with all regulations and laws with impact in each working area: ICH-GCP, GLP, IATA, IRAM, 21 CFR part 11, among others.

Laboratorio Hidalgo participates in External Quality Control Programs: CAP (College of American Pathologists), DGKL (Deutsche Vereinte Gesellschaft ür Klinische Chemie und Laboratoriumsmedizin e.V.-Germany) NGSP (National Glycohemoglobin Standardization Program) and other International and local programs. Laboratorio Hidalgo is accredited by Fundacion Bioquimica Argentina. The above described procedures are conducted with the highest ethical standards.

Contact Information

Laboratorio Hidalgo
Fabiola Santelli, Clinical Trials Manager
Ladislao Martinez 43
Martinez, Buenos Aires B1640EYA Argentina
Phone: 54 11 4798 2012 ext. 300
Fax: 54 11 4793 8108
E-mail:

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