Products & Services / Late Phase Studies

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Late Phase Studies

GVK BIO provides late phase Clinical Research and Data services for India-specific and global trials. The range of services include Trial Operations Management, Medical Monitoring, Regulatory Support, Data Management, Biostatistics, Medical Writing, Pharmacovigilance and Quality Assurance services to Indian and global clients.

“GVK BIO has conducted more than 15 late phase studies across 500 sites in the last 3 years.”

Late phase studies are conducted on drugs after peri- or post-approval from regulatory authorities, with an aim to confirm the appropriate use of the drugs, and to collect data on their safety in real-life settings. The types of late Phase studies include -

  • Phase IIIB Registration Trials
  • Phase IV Trials
  • Observational Studies
  • Health outcome and economic studies (cost-effectiveness, burden of disease, QoL studies)
  • Additional Indication/ Label Expansion Studies
  • Comparative Effectiveness Studies
  • Safety-surveillance Studies
  • Patient Registries
  • Patient Reported Outcome (PRO) Studies
  • Quality Improvement Studies

Product commercialization is an inherent objective behind late phase studies, and is dependent on numerous aspects, which impact its success, especially, efficacy and safety profiles of the product. Therefore, efficient execution of late phase research requires a versatile approach. Having experience in all phases of clinical development of drugs, and being equipped with dedicated and accomplished personnel, we are able to anticipate challenges that may come during your late phase clinical development. We provide clients with strategic, regulatory and operational expertise in developing, implementing and managing late phase studies.

Drivers leading to increase in late phase research

Drivers leading to increase in late phase research

The operational and data collection technology developed at GVK BIO give us an edge over our counterparts, to capture the real time, quality data flawlessly. We customize our operational and data collection strategies according to the needs of our clients, and provide benefits to key stakeholders, including investigators, monitors, and patients. Our data collection procedures are innovative, validated, and compliant to ICH-GCP guidelines and 21 CFR Part 11.  This technology has been efficiently structured, reduces burden of query resolutions, and thereby enhances the data quality and integrity. With this, we can also streamline communication, improve traceability and reduce complexities involved with large data collection procedures.