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The industry has experienced instances where numerous biostudies faced rejection by regulatory authorities due to data integrity issues uncovered during CRO audits. In response, both the USFDA and EMEA have heightened their vigilance, particularly with Indian CROs, leading to more stringent regulatory audits. As a procedural part, regulatory agencies now require the “Monitoring of Biostudies” to be conducted by a qualified person from the sponsor or an independent competent authority.
Performing Clinical and Bioanalytical monitoring is a specialized task that demands skills and a deep understanding of the subject to ensure complete compliance. Monitoring of biostudies goes beyond physical presence at the site; it involves verifying that GCP/GLP processes are diligently followed by the CRO, ensuring the study’s overall compliance.
Edenwell brings a proven track record and extensive experience in managing over 300 biostudies with various complexities. We guarantee that our approach to monitoring ensures the study remains in complete compliance, prioritizing quality to mitigate the risk of biostudy rejection.
Selection of the CROs:
we help our clients to choose the best & competitive CROs for conducting healthy volunteer studies.
Regulatory Consultation & Dossier filing for BE studies. PROMISES
FASTEST TURN AROUND TIME FOR REGULATORY REVIEW & APPROVAL PROCESS.
Project management & monitoring of study conduct:
Managing Bioequivalence Study from Regulatory feasibility to Report submission.
In-depth review of study design, Protocol & Clinical Study Report.
Supports our clients in accurate planning, use of correct BE study design, samples size estimation and close monitoring of various complex bio-studies for various regulatory agencies.
Rich experience in managing & monitoring of pilot and pivotal bioequivalence studies, interpreting pharmacokinetic & statistical results.
Support our clients with root cause analysis, Bio-waiver query response & structured correspondence with the regulatory authority etc.
Pre-Study | During Study | Post Study |
BABE CRO identification & qualification | Monitoring of Screening | Resolution of Monitoring Observations
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Signing off Project Agreement | Monitoring of ICF | Visit Follow-up Letters |
Monitoring Plan | Monitoring of Dispensing | Study Monitoring Visit Report |
Visit Agenda | Monitoring of Dosing | Pharmacokinetic & statistical Report |
Availability of Analytical MVR | Confinement/Clinical Study | Closeout Visit |
Seeking BENOC & T-Licence | Sample Collection & Processing | Analytical Study Report |
IEC Approval | Study Monitoring & Observations | Clinical Study Report |
Shipment of IP & Custom Clearance | Resolution of Monitoring Observations | e-CTD submission |
Sponsor Protocol Approval |
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SIV |
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