Neurology
Services
BA/BE Services
CRO Section
We offer CRO Qualification services which can help the clients across the globe. Our qualified, trained, and experienced Auditors shall perform the Qualification Audit as per GCP, GLP and other regulatory requirements. Our team is capable of qualifying CROs for BA/BE Services.
Medical Writing
Medical writing is an integral part of our work. ClinEnthous offers medical writing services for bioavailability/bioequivalence studies which includes study protocol, investigator brochure, CRF, ICF, SOPs, work-practice documents (WPDs) and Clinical Study Report.
Study Monitoring
We offer various clinical study monitoring services which can help clients across the globe, range of monitoring services. Our qualified, trained and experienced monitors shall monitor the clinical study monitoring for Bioavailability/Bioequivalence (BA/BE) studies.
ClinEnthous monitors ensure the integrity of the study, adherence to protocol, quality of measurements, the safety of Subjects, the collection of valid data, and applicable regulatory requirements.
Regulatory Affairs
ClinEnthous Regulatory team provides comprehensive support for our Sponsors/Clients to overcome the hurdles linked with the requirements of the DCGI, FDA, EMA and Other Regulatory Bodies.
We have a remarkable track record of getting on-time approvals for clinical trials, from different regulatory jurisdictions. We help our Sponsors/Clients understand the requirement of respective Regulatory authorities and assist them appropriately to avoid any delay in approval.
GCP and GLP Audits
We offer a wide range of audit services that can help contract research organizations, clinical research organizations and the pharmaceutical industry for better commitment with quality output.
Our expert team shall analyze the high-risk areas and crucial processes, where chances of errors are high and Identify problems/errors which led to failure.
Our Services include:
> System & Facility Audit
> GAP Audit
> For-cause Investigation
> Regulatory Compliance Audit