Clinical trial monitoring team ensure protocol and regulatory compliance and timely submission of high-quality data. Team consist of registered nurses to doctors, bringing vast therapeutic background and experience. Each monitor is experienced and trained in FDA regulations, ICH guidelines and GCP compliance.
Therapeutic focus is on areas like oncology, neurology and infectious diseases, respiratory system and allergies to pain management and metabolic diseases. Quality focused and affordable Clinical trial monitoring services like: full monitoring-services, on-site and remote, site visits (Site feasibility assessments, site selection, site qualification and initiation visits, initiation visits, Budget and contract negotiations with sites, interim monitoring visits, ongoing site monitoring & management, Remote monitoring via EDC, 100%, Targeted or Risk Based monitoring, Electronic Trial Master File management (eTMF), Clinical Trial Vendor Management, close out - study termination visits ), Source document review, Regulatory document review, source data verification, check of study lists and documents, ISF set-up and maintenance, investigator identification, training of site staff, site staff gcp and protocol training, planning investigator meetings, regulatory document collection, review & management, monitoring compliance with ICH-GCP, study protocol and regulatory requirements, Management/facilitation of IRB/EC submissions, conduct of interim analyses, investigational product accounting, blinded and unblinded IP accountability monitoring reports and follow-up letters, Sponsor Expectation to provide high Quality of data retrieved, Tracking of Query resolution process, Study logistics management, Study drug and non-drug supplies logistics, Tracking regulatory document revisions, Tracking protocol deviations/violations, Tracking subject progression, Product accountability, Providing input into the study protocol, informed consent forms, project risk assessment, training investigational sites and study teams, supporting investigational sites with queries around eligibility, safety etc., reviewing SAEs, coding of SAEs and writing safety narratives, reviewing patient data to identify trends and risks across the study, Report generation.
Straight forward outpatient studies to large complex in patient studies complying to ICH GCP guidelines and local and international regulatory guidelines. Feasibility through site closeout to support clinical trials around the world. Clinical services are tailored to your needs, complimenting product development plans and overarching corporate and quality management policies. All monitoring activities are conducted in accordance with the study protocol, clinical monitoring plan, standard operating procedures, ICH GCP, and applicable regional regulations.
Clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites & conduct on-site monitoring visits throughout the study to oversee data collection, review source documentation and case report forms, ensure regulatory compliance, resolve data queries, conduct interim analyses as requested by clients.
Clinical Research Associates (CRAs) ensure the integrity of the study, adherence to protocol, quality of measurements, safety of Subjects, and the collection of valid data. Global monitoring and site management solutions to clients via international team of experienced professionals.
Clinical Research Associates conduct clinical monitoring for clinical phases studies, recording observational studies & registries.