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Clinic
With the aim of offering a complete solution to our clients, DMH Group has a Clinical Research consultancy, specializing in innovative study projects for clinical trials, clinical evaluations and real-world evidence.
Specializing in innovative study designs for clinical trials, literature reviews and real-world evidence , we offer end-to-end services and functional service delivery solutions.
Our scientific expertise , exclusive focus on clinical studies , flexible, technology-based approach and strategic partnerships make us highly competitive in the clinical research market.
With end-to-end solutions , from design to delivery, we can significantly reduce lead times and costs , helping you expand your development capabilities.
Benefit from faster, more efficient clinical studies.
Clinical Trials
Randomized clinical trials serve as the standard for clinical research. We are prepared to help you plan, design and execute your clinical trial. We offer options for observational, interventional, retrospective and/or prospective trials.
Steps we take for our customers:
Structuring a quality program to monitor all clinical study and clinical research center processes;
Preparation of the clinical research protocol and other documents necessary for conducting clinical trials, with the purpose of supporting registration with applicable regulatory bodies;
Preparation of clinical records (CRF and eCRF), database and other applicable tools for controlling the monitoring of data from a clinical trial;
Structuring the DSMB;
Preparation of the Clinical Drug Development Dossier (DDCM) and Clinical Investigation of a Medical Device (DICD), in accordance with ANVISA requirements;
Preparation or guidance on processes related to Plataforma Brasil and the CEP/CONEP System, including those necessary for registering a CEP;
Assessment, qualification and selection of Research Centers to conduct clinical trials in different therapeutic areas;
Scientific writing.
Clinical Assessments
Clinical evaluations involve the process of collecting, evaluating, analyzing, and reporting clinical data related to a product to verify its clinical safety and performance. We use validated, cutting-edge scientific methodology to plan, execute and report your clinical assessment, according to your target market.
Real World Evidence
Product performance, once released to market and used over time, has been of great interest to regulatory agencies, payers, patients, physicians and sponsors. This type of study design has been used for post-market regulatory studies, quality improvement, benchmarking, among others. Let us know how we can help your business grow.