Clinical Research Management




Long-Term Staffing Solutions
 

Medical Support Staff

CRM provides doctors, nurses, phlebotomists, and laboratory personnel to support clinical research projects.  Our staff is highly educated, experienced, and thoroughly trained in their technical fields.

Overseas Project Support

CRM provides overseas clinical, scientific research, and administrative support (including short- and long-term staffing and logistic support) around the world.  At present, we have personnel in Africa and Asia.  Our services also include procuring and shipping computer equipment; laboratory equipment and supplies; and biological material.

Scientific Research

CRM conducts studies and ground-breaking research in biotechnology.  Our staff is thoroughly trained and immunized to work in biosafety level (BSL) 2/3/4 laboratories.  We provide state-of-the-art research and analysis for a variety of biotechnology research project in biochemistry, microbiology, virology, immunology, molecular biology, veterinary medicine, bacteriology, and toxicology.  We participate in clinical and biomedical research programs at the Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Ft. Detrick, MD.

Other current projects include:

  • Developing multivalent replicon-based vaccines for anthrax, botulinum neurotoxins, staphylococcal enterotoxins, and other agents.
  • Using molecular biological techniques for purifying nucleic acids; gene cloning, expression, sequencing and analysis; DNA restriction mapping and analysis; and nucleic acids amplification and detection.
  • Studying the role of dendritic cells, T cells, and B cells in immune responses to Ebola and Marburg viruses.
  • Studying the activity of antibiotic compounds against bacterial biological warfare threat agents.
  • Performing biochemical procedures, such as spectroscopic assays of protein concentration and structure, isoelectric focusing, gel electrophoresis, Western blots, and protein fractionation by liquid chromatography.
  • Developing quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay for universal detection of Hepatitis E Virus (HEV) of Asian origins and possible HEV of American origins, such as Mexico and U.S. HEV strains.

Vaccine Production

CRM  provides specialized technical and administrative personnel to the WRAIR Pilot Bioproduction Facility, where we research, develop, produce, and test vaccines and other biological products.  We produce these pilotscale (1,000-2,000 doses per finished lot) vaccines under current GMP conditions and all products are tested in compliance with GLP.

These products are released for use in Phase I-II clinical studies under IND applications.  Vaccines produced include those for prophylaxis against shigellosis, meningitis, malaria, dengue fever, HIV, and cholera.

We are also developing and producing conventional vaccines, as well as recombinant and other genetically engineered vaccines.

We have scientific staff who are experts in the following areas of vaccine production:

  • Quality Assurance - audit production and testing to ensure compliance with GMP and GLP regulations.
  • Quality Control - furnish microbiological, serological, and chemical analytical services to support vaccine production.
  • Seed Preparation and Fermentation - culture research-grade seed preparations  to prepare master and production (working)seeds; and develop production seeds by fermentation so that we can grow and harvest up to 300-liter batches of seed organism.
  • Purification - purify concentrated bacteria or soluble antigens using chromatography, centrifugation, chemical extraction, or other methods.
  • Viral Products - inoculate various viral agents into large-scale cell cultures and harvest these agents for further purification and formulation.
  • Formulation and Filling - formulate and fill bulk lots of vaccine as specified in Batch Production Records.

Auxiliary Services

When clients request data and administrative services that support clinical research and biotechnology projects, we recruit staff, develop plans, and deliver services in these fields.

Administrative Services

CRM provides its clients with experienced administrative personnel to meet both short-term and long-term needs.  We can provide clerk/typists; computer specialists; data specialists; event planners; executive administrators; executive assistants; project coordinators, receptionists; and technical writers and editors.

We regularly add skilled staff to provide a broad range of high-quality services.  We also maintain an extensive database of consultants so we can quickly accommodate clients' needs.




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