BA/BE
– End to End service for the Bio-Equivalence (BE) study from Planning of BE study till submission of Dossier to the Agency.
– Assessment of sample size and Cost Analysis for Bio-Equivalence study.
– Initiation, review and finalization of BE study Protocol.
– Application for BE NOC and Test licence application from CDSCO (India).
– Monitoring of BE study and preparation of Monitoring Study Report.
– Review of Bio-Equivalence documents like Case Record Form (CRF), AE, Deviation and Source Document.
– Review and finalization of Clinical, Bio-Analytical and Pharmacokinetics Statistical study report.
– Handling and response to critical queries raised by Regulatory Agency
– Compilation of Document in eCTD format
We are specialized in both the management and monitoring of clinical trials from phase I to IV and monitoring of Phase I, BE/BA studies in India as well outside India.
A team of highly qualified, experienced and skilled people for fulfilling various goals of our esteemed clients. We have monitored a number of BA/BE studies and Clinical trials. We have an experience of auditing more than 15 BA/BE CROs in India for a number of times.
Our early-stage monitoring services are provided by monitors who have good experience in monitoring and managing Phase I, BE/BA studies or have graduated with a Master’s Degree in Pharmacy. They are highly qualified, knowledgeable professionals with extensive experience dedicated to early-stage studies. The sponsors have the opportunity to review any profile prior to approving monitoring personnel for their study. You can trust effective and extremely thorough monitoring.
CRO Audit:
We provide technical and quality system audits of the facility to assess the level of compliance for the existing facility and quality systems for the project requirements. These services are offered by our auditors who are vastly experienced, well qualified and have very handy experience in this area.
System audits cover the review of the following departments,
– Clinical
– Bioanalytical
– PK and Statistics
– Quality Assurance
– Quality Control
– Information technology
– Training
– Archival.
Clinical Site Management & Monitoring:
Monitoring and site visits include check-in, dispensing, dosing, sampling, sample separation, Trial master file, and raw data review.
– Site management & monitoring activities
– Development of the monitoring plan
– Proactive monitoring approached while on site
– Source data verification
– Preparation of Monitoring reports, observation report and compliance report.
– Monitoring close out meeting.
Bioanalytical Monitoring:
We conduct GLP and Bioanalytical audits of investigative site operations to determine the adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations.
– Subject sample analysis
– Sample processing-
– Method development and method validation verification
– Raw data review.