Our dedicated team of Clinical Operations experts conducts phase trials, observational studies, and more.
a) Study Design and Development
● Protocol Development
● Informed Consent Document
● CRF Designing and development
● Study design and its execution plan
● Site selection and subject recruitment plan
● Development of statistical plan
● Planning and conduction of Investigator meetings
b) Project Management
● Site feasibility and start up
● Effective strategies for subject recruitment and retention
● Adherence to timeline
● Accurate documentation
● Adequate training for all the staff involved
● Efficient contract and finance management
c) Site Management
● Assistance in Site feasibility assessments and site contracts
● IRB submissions and approvals
● Assist the PI in subject recruitment and retention
● Assist PI in maintaining the Site Master File
● Coordinating and scheduling subject visits
● Drug accountability and dispensing
● Effective maintenance of study related logs
● Effective followup with subjects
● Assist CRA during monitoring visits
● Drug and sample shipment
● Study subject payments
● Assist in Data entry, resolution of queries and AE/SAE reporting
d) Clinical Monitoring
● Site Identification and feasibility assessment
● Collect, review and process the Essential documents
● Complete monitoring services: Qualification, Initiation, Interim and Close-out visits
● Reviewing Eligibility criteria and proper documentation of Informed Consent
● Thorough review of Data collection
● Source Documents and CRF Verification
● Reviewing Site documents
● Reviewing on time reporting of AEs/ SAEs
● Effective mediation between the site and our organization
● Ensuring safety, regulatory and other necessary compliance
● Effectively training all the study personnel
● Ensuring trial completion with minimized deviations and no violations
● Review of accountability
● Oversee accurate logging and documentation
● Ensure compliance and implementation of study protocol
● Study close out and Database lock
● Completion of visit reports within the timeframes