In its 21 years of experience, OPIS has had the opportunity to manage trials in several other therapeutic areas, including:
Infections and infectious diseases
Other Areas of Expertise:
When it comes to rare disease and pediatric oncology trials, challenges and uncertainties are numerous. The importance of applying a study design that meets rigorous standards, minimizes bias, has appropriate likelihood of achieving scientifically adequate results and minimizes the number of patients to be enrolled/randomized, cannot be underestimated. It is however the uniqueness of the single orphan disease that needs consideration most. At OPIS, with years of valuable experience gained in the field, we strive to collaborate with a much wider audience of stakeholders to optimize possibilities of having adequate patient numbers, acceptable patient retention as well as cost advantages. These include patient and caregiver networks, consortiums or other non-profit organizations and even specialized data platforms.
OPIS experience include rare disease indications in Cardiology, Genetic diseases, Immunology, Hematology, Oncology, Rheumatology and Musculoskeletal indications.
Understanding the very burdensome situation of patients and caregivers having to live with disabilities or disease- especially children with disabilities or disease- has moved OPIS to assist its clients with solutions where all stakeholders can work together towards making trial participation as friendly as possible. It takes a lot of experience and clinical trials require proper conceptualization. A team of regulatory and statistical experts at OPIS support Sponsors with required additional regulatory aspects such as pediatric development plans and statistical considerations.
Clinical Investigations for medical and diagnostic devices
With the new European Medical Device Regulations (MDR) and the In Vitro Device Regulations (IVDR) that came into force recently, OPIS collaborates with expert consultants in the industry and a team of UNI EN ISO 14155 trained staff to assist clients through challenging clinical compliance issues.
Nutraceutics and FSMPs
OPIS has assisted clients with clinical studies related to food supplements and Foods for Special Medicinal Purposes (FSMP). Clearly different from drug trials, food trials are currently regulated under the Food Supplements Directive (FSD) 2002/46/EC.
OPIS can provide nutraceutical companies who want to acquire clinical/scientific data as part of their pre- or post-market authorization process, with concept development and protocol, planning, regulatory submission, proper trial execution as well as compliant data handling procedures, statistical analysis and standard operating procedures to ensure quality system based compliance.
Observational Research and Real World Evidence Studies
OPIS holds vast experience in prospective as well as retrospective observational studies and has managed study populations ranging from small consumer populations to very large groups in epidemiological research. Registry studies and Real World Evidence studies with patients in usual care, have become very popular especially in cardiology, oncology and infectious disease indications. OPIS assists clients for this type of data collection, analysis and interpretation with a rigorous methodological yet innovative approach.
OPIS can also offer state-of-the art technological solutions for the collection and processing of patient reported information and outcomes.