Msource Medical Development is a full-service Contract Research Organization providing clinical development services to the pharmaceutical, biotechnology, and medical device industries.

MSOURCE performs studies all over Europe, through affiliations in Belgium, The Netherlands, UK, Germany and Poland, while the US is covered by two trusted CRO partners. At MSOURCE we will approach your international trial in the most efficient way. The centralized project management will ensure high-level support with short communication lines towards both you as a sponsor and the operational team. Thanks to our monitoring regions we can cover the entire study region in a cost-effective way.

Our mission is to provide excellent clinical research services according to the highest quality, professional, ethical and scientific standards.

By applying optimised research process management, integrated communication facilities as well as intensive training of our people, we are able to offer our clients sustainable benefits.

MSOURCE has an ISO 9002 certified Quality Management System and is dedicated to continuous quality improvement.

In our vision, quality and efficiency go together in clinical research, which makes us your partner of choice in clinical research!

Msource Medical Development has five business units:

MSOURCE performs phase I to IV clinical trials, all the way from study design to integrated clinical study report.

Whether you outsource an entire clinical trial or just part of the work, you'll have the advantage of working with one of the most committed and experienced teams in the field. Our monitoring and project management teams are experienced and trained in specific therapeutic areas, including:

• Cardiology
• Infectious Diseases
• Central Nervous System
• Oncology
• Orthopedics
• Gynecology

CTM offers the following services:

• Project Management
• Clinical Trial Design
• Protocol Development
• CRF & Database Development
• Quality Assurance
• Investigator Recruitment
• Initiation
• Monitoring
• Close Out
• Data Management
• Biostatistics and SAS®
• Medical and Scientific Writing
• Drug Safety Management
• Scientific Publications
• Site Services, Research Nursing
• Pharmaco-Economics Consulting

The CDS group of MSOURCE Medical Development is an ISO 9002 certified organization that performs data management and biostatistics according to ICH-GCP and other applicable guidelines for the pharmaceutical, biotech and medical device industry.

MSOURCE data management solutions, such as EDC and on-line query handling will help you to maintain even critical timelines.

Msource CCS offers advantages over traditional data management services because both patient data and management data are:

• managed by integrated processes and workflow
• stored on one secure location
• globally accessible over the internet
• auditable at any time
• ready for immediate analysis

CDS offers:

• clinical data management services, Oracle Clinical® and several EDC platforms)
• biostatistics and SAS® programming
• a secure production environment for both paper and electronic clinical trials
• medical writing services

MSOURCE Medical Development provides expertise in quality assurance. Our clients benefit from the substantial experience and clinical background of our consultants, trainers and auditors.

QA services are pro-active as well as retroactive. A well-balanced pro-active QA program of GCP Training and SOP Consulting will streamline clinical trial related work and will reduce the amount of significant findings during subsequent QA audits. MSOURCE QAR offers following services:

• Clinical QA Auditing
• SOP Consulting
• GCP Training
• Quality System Consulting
• Clinical Software Validation
• Clinical Regulatory Consulting for International Ethics Committee submissions
• Clinical Regulatory Consulting for International Competent Authority approvals

MSOURCE International CCH services offer the flexibility to adjust the size of your local or international project team to the current workload. Your studies will run efficiently without increasing headcount or contracting out the entire project.

Trial management remains your company's responsibility, while MSOURCE provides you clinical research professionals.

Whether you need CRA's, clinical data coordinators, project managers, data managers, statisticians, SAS programmers, medical writers or clinical project assistants, we will do everything possible to meet your needs.

MSOURCE CCH invests in excellent personnel by giving training, coaching and by recruiting highly qualified people.

MSOURCE PVM department offers:

• EU CTD Compliant reporting
• Support in most aspects of the handling of SAE’s
• Request of EudraCT numbers
• Medical, scientific consulting

Belgium (Headquarters) – MSOURCE BVBA
Mechelsesteenweg 455 B5
B-1950 Kraainem (Brussels)
Belgium
Tel: +32 (0)2 768 01 66
Fax: +32 (0)2 767 81 35
E-mail: info@msource-cro.com

Netherlands – MSOURCE BV
Becanusstraat 13 B09
6216 BX Maastricht
Netherlands
Tel: +31 (0)43 347 57 80
Fax: +31 (0)43 343 86 24
E-mail: info@msource-cro.com

Meerwal 17
3432 ZV Nieuwegein
Netherlands
Tel: +31 (0)30 638 26 65
Fax: +31 (0)30 638 29 60
E-mail: info@msource-cro.com

UK – MSOURCE Ltd
6th Floor, Hamilton House 111 Marlowes
Hemel Hempstead, Hertfordshire
HP1 1BB – United Kingdom
Tel: +44 (0)1442 450410
Fax: +44 (0) 1442 450451
E-mail: info@msource-cro.com

Poland – MSOURCE Sp. Z o.o.
Wisniowa 40B/8
02 - 520 Warszawa
Poland
Tel: +48 (0)22 6464240
Fax: +48 (0) 22 6469932
E-mail: info@msource-cro.com

Germany – MSOURCE GmbH
Lütticher Strasse 281
D-52074 Aachen
Germany
Tel: +49 (0) 241 7 50 07 74
Fax: +49 (0) 241 7 50 07 65
E-mail: info@msource-cro.com

Promenadeplatz 12
D-80333 München

Germany
Tel: +49 (0) 89 21 01 91 12
Fax: +49 (0) 89 21 01 91 50
E-mail: info@msource-cro.com

USA
Msource - Bailer
715 Route 15 South
Lake Hopatcong, NJ 07849
Fax: +1 973-663-6041

2678 Bishop Drive, Suite 100
San Ramon, CA 94583
Fax: +1 925-901-1574