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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. 

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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.

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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​

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 CLINICAL TRIAL INVESTIGATIVE SITES

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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 multi-specialty clinical investigative sites having extensive experience in conducting drug development clinical trials according to ICH Good Clinical Practice Guidelines.

 

These high-performance international investigative sites are primarily focused on conducting US FDA Phase 2 and Phase 3 drug development clinical trials. Covering a multi-million, diverse ethnic catchment area population, these clinical facilities have preferred access to a fast growing and highly compliant, local clinical trial subject populace. 

 

With 70% - 80% drug development clinical trials resulting in failure due to patient recruitment inability or delays, the DELTA HEALTH operated international investigative sites in Asia take pride in offering a quick start-up with enthusiastic investigators, fast patient recruitment and excellent retention rates.

 

Modern, internationally certified clinical laboratories and diagnostic facilities provide dedicated support throughout the duration of ongoing clinical trials.   

 

Offering a One-Window-Operation with a very fast turnaround for local regulatory and IRB approvals, these clinical facilities in Asia are directly managed by the DELTA HEALTH team members stationed locally on the ground. These Delta clinical trial specialists also have in-depth knowledge and hands-on experience with the direct management of successful US FDA clinical trials and investigative sites.

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

 

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