Company

More about us

Expertise

In the course of over 25 years, we have continuously enlarged our knowledge and expertise. M.A.R.C.O. provides medical and statistical services for clinical trial projects for national and international pharmaceutical companies, SMEs, start-ups, universities and university hospitals. M.A.R.C.O. is well known for its reliability and stability throughout complex projects for clients all over the world and gathers expertise from various disciplines.

Fields of experience

  • Pre-Clinical / Animal Studies
  • Clinical Trials Phase I-IV
  • Non-Interventional Studies (NIS)
  • Investigator Initiated Trials (IIT)
  • Post Market Surveillance (PMS)
  • Drug / Therapy Development
  • Medical Devices
  • Broad coverage of medical indications

Philosophy

The main objective of our organization is to provide high-quality services with qualified and dedicated staff to achieve highest possible customer satisfaction. All work processes at M.A.R.C.O. follow the fundamental principles of science.
Why M.A.R.C.O.?
  • Adaptive, proactive project management
  • Single point of contact philosophy
  • Generation of regular status reports
  • Owner-operated, flat hierarchy
  • Tailored services
  • Honest and transparent partnership
  • Rapid compilation of reliable study results
  • Quick responses to sponsor inquiries
  • Vivid feedback culture to foster meaningful impulses
  • Experienced and dedicated project teams
  • Joined internal processes
  • Professional support throughout the lifetime of your application

Quality & Security Standards

M.A.R.C.O. has implemented suitable processes to ensure high quality standards, thorough data protection, as well as IT-based security.

High Quality Standards

  • High scientific standards with specific SOPs
  • Compliance with regulatory requirements (BfArM, EMA, FDA, WHO, PMDA)
  • Compliance with EU Regulation 536/2014
  • GCP- and ICH-compliance
  • 21 CFR Part 11 compliance
  • QM system guided by principles of Total Quality Management and ISO 9001
  • Validation processes based on GAMP Good practice guide
  • Internal and external audits (periodically)
  • CDISC competency
  • GDPR / DSGVO compliance

Thorough IT Protection Systems

  • Data stored in Germany – German Data Protection standards
  • Data security: Data center ISO/IEC 27001 certified
  • Surveillance / alarm system based on 24 hours external monitoring
  • Firewalls (two),
  • Multiple virus protection software
  • Two-level back up

Development

Dr. rer. nat. Manfred Wargenau has founded M.A.R.C.O. in May 1997 and operates it since then. Before that, he worked at the University Medical Center Hamburg-Eppendorf and a couple of well-known international pharmaceutical companies. Started with statistical services, M.A.R.C.O. has continuously enlarged its service portfolio.

As an owner-operated institute for clinical research, M.A.R.C.O. has successfully completed more than 1700 projects for over 160 customers worldwide. Our services have already been applied in the area of clinical research in cardiology, diabetology, dermatology, immunology internal medicine, neurology, oncology, orthopedics, pneumology and many more. In addition, our products are used for research on natural remedies and medical devices.

Our ambition is to deliver high quality products and services, and to achieve highest possible customer satisfaction. M.A.R.C.O. stands for honest, professional, flexible and transparent partnership.

Founder of M.A.R.C.O - Dr. rer. nat. Manfred Wargenau

We would be happy to answer your questions about our services personally.

contact@marco-institut.de