DELTA HEALTH GROUP
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EXPERIENCE.....INTEGRITY.....QUALITY
Clinical Development
The DELTA HEALTH GROUP collaborates with other innovator companies to partner and co-develop therapeutic candidates in the clinical phase of the development process.
Our team members have extensive clinical development experience in diverse specialties and indications, including:
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Cardiovascular Diseases
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Dermatology
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Oncology
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Endocrinology
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Gastroenterology
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Nephrology
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Hematology
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Neurology
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Ophthalmology
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Urology
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Pain Management
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CNS
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Immunology / Autoimmune
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Pulmonary / Respiratory
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Psychiatry
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Rheumatology
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Infectious Diseases
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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 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 have partnerships with specialized pathology laboratories in the United States offering comprehensive expertise in:
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Flow Cytometry - Immunophenotyping for leukemias and lymphomas
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Cytogenics - Study of Chromosomes for various cancers
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Fluorescent In-Situ Hybridization (FISH) - studying chromosomes with various breakpoints in different types of cancers
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Next Generation Sequencing (Molecular Genetics) - DNA and RNA testing for various cancers
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Digital pathology
CLINICAL TRIAL INVESTIGATIVE SITES
Our Clinical Trial 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
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We have long-term exclusivity agreements with prominent teaching hospitals and clinics in Asia 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
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With advanced infrastructure and world-class medical facilities, 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
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The clinical trial facilities in Asia are directly managed by the DELTA HEALTH team members stationed locally on the ground. These Delta Specialists 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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With 70% - 80% drug development clinical trials resulting in failure due to patient recruitment inability or delays and another significant number falling short of meeting primary objectives, the DELTA HEALTH operated investigative sites in Asia take pride in being able to take challenges head-on and make smart decisions to overcome common obstacles seamlessly. The EMR and EDC savvy DELTA site teams on the ground work diligently with key stakeholders to facilitate successful completion of the clinical trials and ensure availability of robust data from studies conducted at our sites
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Modern, internationally certified clinical laboratories and diagnostic facilities with in-house CT scans and MRIs provide dedicated support throughout the duration of ongoing clinical trials
We are also anticipating an early startup of our state-of-the-art Phase 1 study clinics in the Europe-Asia region
Fast-Track Regulatory and IRB Approval
With our streamlined, one-window-operation, the local regulatory and IRB approval process in Asia goes through a very fast turnaround to facilitate an expedited start-up of clinical trials.