Clinical Auditing and Training » Clinical Audit Services
Max Neeman International provides a full range of clinical audit services for clinical trials in India . Following each audit, comprehensive and confidential reports and audit certificates are produced according to Max Neeman International standard operating procedures or client specifications. Clinical Audits encompass all aspects of the clinical development process:
Trial Master File Audits - Comprehensive review of essential documents according to ICH GCP, Indian GCP and client SOPs.
Investigator Site Audits - Audits of pivotal or supportive studies involving single or multiple investigator sites.
Preparation for Regulatory Inspections - Regulatory authorities are now carrying out inspections in accordance with the Indian GCP. Full mock inspections can be carried out or advice and training of staff provided.
CRO and Clinical Laboratory Audits - Pre-contractual audits, evaluation as preferred service providers or audits involving ongoing projects.
Database Audits - Audit of a sample of data from a locked database according to either the client or Max Neeman SOPs.
Clinical Report Audits - Audits of clinical reports against client SOPs and ICH GCP requirements.
GCP and Audit Training - We train your team so that they reach high quality monitoring standards and work in full compliance with the applicable SOPs and national regulations as well as ICH-GCP guidelines.
Preparation of Standard Operating Procedures - Advice and preparation of SOPs to assure compliance with GCP requirements.
Support and Advice - Additional support for QA units to meet short term needs at times of overloading. Advice on general issues relating to GCP.
