CRL.Medinet (Europe)

CRL.MEDINET is a GLOBAL CENTRAL LABORATORY ORGANIZATION with more than 10 years of experience.

We have fully standardized laboratories in the USA, the Netherlands, Australia, Japan, Singapore and South Africa, serving the Americas, Europe, Australia, Asia, China, Indochina, Japan and Southern Africa respectively.

Our business is:



• To provide Central Laboratory services including clinical laboratory tests, biomarkers and analytical capabilities
• To provide the logistical and operational support necessary to make central laboratory services work.

Organization Statistics:



• Revenue: Over $ 200 million (USA) per year
• Growth: 15 - 20% over the last three years
• Staff: over 1000 FTE worldwide
• Active Studies: more than 600
• Global Studies: more than 150

Customer Focus: personalized and customized services within long term relationships.

Quality & Compliance: demonstrable quality assurance and regulatory compliance, to satisfy FDA requirements on a global scale.

A Standardized Global Capability: standardized laboratory testing in all geographical locations and global data management.

Testing



• Safety Tests: standard safety profiles for clinical research – phases 1 through IV
• Specialized Tests: for inclusion/exclusion and efficacy markers / biomarkers
• Analytical Tests: drug levels in patient samples under GLP conditions
• Other: molecular biology and genotype testing

Operational support and Logistics:

Initiation



• Consultation: on protocol laboratory issues and details
• Supplying Investigator Sites: visit kits, manuals, & stationery, shipping supplies & documents
• Investigator Meeting Attendance: presentation of laboratory aspects

Start Up

Courier Samples: from sites to lab. We use top bulk couriers for safety testing providing the best value for money. All other shipments are tailor-made specialty services, meeting your timeline and budget.

• Help Desk: telephone and email helpdesk for sites

Study conduct



• Reports: enrollment and other reports to sponsor as required
• Results: test results to sites – fax, regular mail, email
• Data Transfers: to sponsor in sponsor preferred format, scheduled or ad hoc
• Online Access: to study data and statistics

Study Closure



• Database Cleaning: Is a continuous process resulting in better than 99.5% clean demographics before database lock
• Archiving: Study required data and materials for more than 15 years

Standardized Laboratory Sites:



• USA - Kansas City , (Lenexa, KS) serving the USA, Canada and Latin America
• Europe - Breda, the Netherlands, serving all of Europe and Scandinavia, Russia, Eastern Europe and Israel
• Australia - Sydney, New South Wales, serving Australasia (Australia, New Zealand and neighbors)
• Japan - Tokyo, serving Japan, Korea and neighboring territories,
• Southern Africa - Cape Town, South Africa, serving South Africa, Namibia and Botswana.
• Singapore - serving SE Asia Indonesia, Philippines, Taiwan, and China

Project management at CRL.Medinet is a vital service, whereby a single trained and experienced individual coordinates all aspects of our service for each study, and acts as the point person for all communication.

At each laboratory, Laboratory Study Coordinators manage your studies:



• Trained personnel experienced in conducting clinical research (laboratory medical technologists and healthcare specialists).
• Each study is assigned to a single (lead) laboratory study coordinator
• For global studies there is a study coordinator appointed in each laboratory concerned, with the lead study coordinator based in the country where the study originated (usually USA or Europe)
• These individuals convert your protocol requirements into a customized and personal service.

CRL.Medinet serves more than 50 pharmaceutical organizations and various CROs, from big pharmaceutical companies to small biotechnology companies.
Master Agreements with many customers, six of whom are in the top 10 global pharmaceutical companies.

John Penman, MD, MBA, Director of Clinical Trials and Medical Services
8433 Quivira Road
Lenexa, KS 66215 USA
Phone: +1-913-693 2574, +1-888-265-7956
Cell: +1-913-488 1021
Fax: +1-913-492-4316
E-mail: john.penman@crlmedinet.com
http://www.centerwatch.com/professional/prv280.html

Contact Information

CRL.Medinet (Europe)
Robert Hoek, MSc, Sales Manager Clinical Trials
Bergschot 71, 4817 PA
Breda The Netherlands
Phone: +31-76-573-7526
E-mail:

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