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SPEARHEADING
THE WORLD OF 
MEDICAL INNOVATION

The DELTA HEALTH GROUP collaborates with other innovator companies to partner and co-develop therapeutic and preventative new drugs, biologics and medical device products in the clinical phase of the development process. 

Our team members have extensive clinical development experience in diverse therapeutic areas, including:

  • Cardiovascular Diseases

  • Dermatology

  • Oncology

  • Endocrinology

  • Gastroenterology

  • Nephrology

  • Hematology

  • Neurology

  • Ophthalmology

  • Urology

  • Pain Management

  • CNS

  • Immunology / Autoimmune

  • Pulmonary / Respiratory

  • Psychiatry

  • Rheumatology

  • Infectious Diseases

  • Orthopaedic Surgery

 

Use of safe drugs, biologics and medical devices is critical to their pre- and post-approval therapeutic success. Over two decades of experience working directly with the US FDA and Health Canada has greatly enhanced our expertise in the areas of clinical development and drug safety / pharmacovigilance.

 

With extensive experience leading to full approvals, the DELTA HEALTH GROUP also offers a one-stop shop for US FDA INDs, NDAs, 505(b)(2)s and ANDAs. 

 

In addition to the United States Food and Drug Administration (FDA) and Health Canada, the DELTA team also has experience in working with the European Medicines Agency (EMA), Ministry of Health Mexico, Argentina Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) and the Ministry of Health Türkiye.

To support our clinical development programs, we also have exclusive partnerships with specialized pathology laboratories in the United States offering comprehensive expertise in:

 

  • Flow Cytometry - Immunophenotyping for leukemias and lymphomas

  • Cytogenics - Study of Chromosomes for various cancers

  • Fluorescent In-Situ Hybridization (FISH) - studying chromosomes with various breakpoints in different types of cancers

  • Next Generation Sequencing (Molecular Genetics) - DNA and RNA testing for various cancers

  • Digital pathology

 CLINICAL TRIAL INVESTIGATIVE SITES

The DELTA HEALTH GROUP operates its global network of dedicated and strategically located clinical trial investigative sites based on the maxim.....EXPERIENCE.....INTEGRITY....QUALITY.

 

We have long-term exclusivity agreements with globally located prominent teaching hospitals and clinics to operate and manage state-of-the-art clinical investigative sites having extensive experience in conducting drug development clinical trials according to ICH Good Clinical Practice Guidelines.

 

A number of these high-performance international investigative sites covering a multi-million, diverse ethnic catchment area population, have preferred access to a fast growing, highly compliant local clinical trial subject populace. 

 

Independently audited and qualified, a number of these clinical facilities are recipients of the prestigious "Best Clinical Trial Site" recognition. These international investigative sites, primarily focused on conducting US FDA Phase 2 and Phase 3 drug development clinical trials have very low screen-failure and excellent patient retention rates.

 

Offering a ONE WINDOW OPERATION with a very fast turnaround for local regulatory and IRB approvals, these clinical facilities are directly managed by the DELTA HEALTH team members who have in-depth knowledge and hands-on experience with the management of successful US FDA clinical trials and investigative sites.

We are anticipating an early startup of our state-of-the-art Phase 1 study clinics in the Europe-Asia region.

 

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