Orisole provides an extensive clinical site monitoring and management services from qualification and initiation to site closeout. Our CRAs (Clinical Research Associates) are proficient, knowledgeable and skilled professionals with comprehensive clinical research experience and are well versed in communicating within the study team members and multiple sites. Our CRAs perform all the monitoring activities in accordance with ICH GCP guidelines, SOP, Study Protocol and applicable regulatory requirements. RPM develops Sponsor agreed monitoring plan for each trial project.
Contract Research Organization (CRO) Clinical Research Associates (CRAs) with local expertise
Full Service Onsite selection, initiation, routine, and close-out visits
Risk-based Monitoring Source data verification (SDV) and remote data reviews
Orisole Solutions provides full clinical data management services for pharmaceutical and biotechnology companies focused on the development of new drugs. We guarantee high quality clinical data from phase I trials to postmarketing studies.
Orisole Solutions offers biostatistics and SAS programming services for pharmaceutical and biotechnology companies focused on the devolpment of new drugs. All our services are provided in compliance with ICH guidelines (E9 Statistical Principles for Clinical Trials and E3 Structure and Content of Clinical Study Reports).
Orisole Solutions provides pharmacovigilance services for pharmaceutical and biotechnology companies dedicated to the development of new drugs. We manage adverse events (monitoring, listings, and reporting) through a fully E2B (R3) compliant safety database.
We have particular expertise in cancer studies, which differentiates our service offerings. Our deep knowledge and wide experience in oncology constitute a tremendously valuable asset for sponsors dedicated to cancer drug development.
We manage both adult and pediatric clinical studies globally in solid tumors (soft-tissue sarcomas, bone tumors, gastrointestinal, endometrial, ovarian, lung, and breast cancer), hematologic malignancies (leukemia and lymphomas), and rare cancers.
We have strategic partnerships with research groups in the United States and Europe, in order to plan and execute international trials in a quick and well coordinated manner, facilitating trial organization for sponsors.
BA | BE Studies
At Orisole we share your passion for the advancement of medicine and understand the need for innovative solutions to accelerate your product’s time to market. Exceptional team chemistry and dedication to service are the hallmarks of our workforce.
We, the premier service provider of Clinical Pharmacology Services, specialize in providing safe and ethical research solutions for Bioequivalence - Bioavailability studies.
Our domineering experience in conducting a full range of bioavailability / bioequivalence clinical studies has given us a complete understanding of the generic development process, which gives confidence to our sponsors that the outsourced project will be completed professionally and with most expeditious economic way possible. Our large infrastructure ensures the quick accommodation of your project for male / female or special populations.
The pharmacokinetic, bioavailability and bioequivalence studies are conducted at our facilities in strict compliance with national and international regulatory guidelines that are monitored by independent quality assurance team. With fewer levels of management, our staff members are able to respond quickly to a client’s request and initiate action without having to consult a committee. Our team members take ownership of the project, providing clients with a more personalized, strategic approach to clinical management in the context of the phase, location and objectives of the study.
At Orisole, we offer specialized services in the following types of studies:
Fasting and Fed condition
Single and multiple dose in healthy subjects
Drug-drug interaction, drug-food interaction
Various Routes of Administration
Special | Patient Population (PK | PD) studies
Orisole Solutions LLP is a dedicated health care company to provide end-to-end services and solutions. We help our clients address their most critical problems by bringing together the capabilities of a full-service CRO, a technology-led life sciences services provider across clinical, regulatory and safety services.
We pride ourselves on being flexible, innovative, reliable, and passionate. We are motivated by the success of our clients and thrive on working together with clients as partners, across geographies, time zones, and cultures.
As experts in electronic data capture for patients in clinical trials, HG Solutions has been involved in clinical development, helping sponsors and CROs to bring simplicity to the collection of clinical trials data for both patients and sites.