Who we are?
BEMONIT provides consulting and monitoring services for bioequivalence.
It is an OPC organization, having more than 15 years of core bioequivalence experience in conducting and monitoring bioequivalence studies, clinical studies and patient based studies.
Experience in all type of bioequivalence studies which includes, Pharmacokinetic endpoint studies, Pharmacodynamic endpoint studies, Clinical endpoint studies (Patient based), In-Vitro endpoint BE studies (Disso / IVRT / IVPT), Population based bioequivalence study (PBE), IVIVC analysis etc.,
Services
The ICH E6(R3) Guideline for Good Clinical Practice, adopted on 06 January 2025, mandates strict execution and independent oversight rules for sponsors:
- Personnel Qualification (Section 3.4): The sponsor (Pharma Company) must utilize appropriately qualified individuals for all assigned activities throughout the entire clinical trial process.
- Independent Monitoring (Section 3.11.4): The guideline explicitly emphasizes that trial monitoring must be performed by individuals who are not involved in the clinical conduct of the trial at the specific site being monitored.
Monitoring is an ICH-GCP requirement for all Bioequivalence studies / clinical trials and should be conducted under the responsibility of the sponsor (ICH-GCP §5.18). Monitors should be appointed by the sponsor and their qualification and training should be documented (ICH-GCP §5.18.2).
Quality assurance/quality controls activities that are part of the quality system of the clinical site (BE CRO facility) cannot be considered monitoring. As explained above, monitors should be appointed by the sponsor and the activity should be performed by the sponsor or appropriately delegated.
Quality assurance/quality controls activities that are part of the quality system of the clinical site (BE CRO facility) cannot be considered monitoring. As explained above, monitors should be appointed by the sponsor and the activity should be performed by the sponsor or appropriately delegated.
Regulations state that sponsors are required to ensure proper monitoring of the study (21 CFR 312.50 and 812.40) and to select monitors qualified by training and experience to monitor the study (21 CFR 312.50, 312.53(d), 511.1(b)(8)(ii), 514.117, and 812.43(d)).
Monitoring is an essential activity to ensure the quality of the clinical trial / BE study. The main responsibility of the monitor for a BE study is to ensure that the study is conducted in accordance with the protocol, GCP, GLP and applicable ethical and regulatory requirements. This includes verification of the use of correct procedures for completion of CRFs and verification of the accuracy of data obtained.
