Regulatory Compliance Services in CRO’s
India over the last ten years has developed significant capabilities in medical trials as well as certain in project and data management. The country has been able to offer prominent cost savings of 50 to 60 percent in clinical trials. With research discovery holding near to one-third of the R&D expenditure for the western medical industry, outsourcing to low expense countries is a logical move. As the regulatory and financial pressure expands on the European and US medical industry, it is expected to propel the expansion in the Indian medical trial market as well.
This has resulted in the CRO’s in India to come up with innovative clinical laboratory services that helps in disease treatment and drug development. Medical technicians’ research and carry out various medical studies and examine human blood samples and analyze the effect of drugs on the blood. Along with other various service offerings, CRO’s give importance to regulatory compliance services and quality assurance. There is a dedicated team for service and audit compliance backed up by in-depth knowledge on local regulatory processes and effective associations with numerous regulatory agencies, assuring competence in clinical trial approval procedures.
Regulatory compliance services in leading CRO’s has successfully completed numerous audits from various Indian and global regulatory agencies. At the same time, there have been study submissions on various countries. The wide range of regulatory services provided are as follows:-
Formulating regulatory strategies
Replying regulatory agency queries
Renewing Import License
Procuring drug import licenses
Follow-up and submissions of the application
Tracking applications and approvals
Submission of Clinical Safety Report (CSR)
Safety Reporting
Procuring NOC for export of biological samples
Compiling clinical trial application
At the same time, when it comes to QA eminent CRO’s have got a comprehensive quality assurance team to monitor various clinical activities with a desired quality. The team concentrates on quality that permeates all the procedures within the domain of every service. Furthermore, there are meticulous executions done by the Quality Assurance and Quality Control procedures. Quality Assurance initiatives cover Bioanalytical, Clinical, Statistics, Internal Audits and Reporting by the QA team for area specific SOP compliance. Furthermore, other in-house capabilities that CRO’s perform comprise Site Audits, Vendor Audits, Process/System Audits, Document Audits that includes protocol, clinical study reports and important clinical trial documents.
Eminent CRO’s in India have their own Biometrics team that are competent and assist in all Clinical Trails phases. The service portfolios are generally used by the biotechnology, pharmaceutical, diagnostics, device and research organizations. These services comprise protocol writing, report writing and statistical analysis and equipped with advanced software’s such as SAS, S-Plus, SPSS, R, StatXact, PASS, nQuery, WinNonLin, Kinetica, SDMS and MedXview.
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