DNA samples can reveal essential information about hereditary factors related to efficacy and safety of a new pharmaceutical, paving the way for individualized therapy. DNA samples are nowadays regularly collected in connection with clinical trials. They are becoming an important link in ensuring a safe and efficacious dosage of the new pharmaceutical and in improving its risk benefit ratio in correctly identified groups of patients. Information gained from studying the genetic samples is reliable only if samples are available from a large and representative group of study subjects.
Similarly, crucial information collected during large clinical trial programmes and summarized in registries and databases can reveal important knowledge for the benefit of physicians and patients.
Since utilization of DNA samples, registries and databases as a part of clinical trials is a relatively new phenomenon a pharmaceutical company may phase unforeseen challenges regarding submission of protocols, pharmacogenetic substudy protocols, and their amendments as well as patient information and informed consent and when dealing with ethical committees and regulatory bodies.
M.I.T. Consulting can help you in reaching your goal and limit the time wasted.
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Marjut Ranki-Pesonen, MD, PhD
Senior consultant with expertise in pharmacogenetics
Veijo Ikonen, MSc
Senior consultant with expertise in risk analysis and management