Clinical Operations

Effective clinical operations are the backbone of successful clinical research. At Neuheit Research, we provide end-to-end Clinical Operations services in India, supporting clinical trials from site feasibility and regulatory readiness through study close-out. Our operational framework is designed to ensure ethical conduct, regulatory compliance, data integrity, and efficient trial execution across all phases of a clinical study.

We understand the operational and regulatory complexities involved in conducting clinical trials in India. Our Clinical Operations services are delivered in alignment with NDCT Rules, 2019, CDSCO and DCGI requirements, ICMR National Ethical Guidelines, and ICH-GCP, ensuring that studies are conducted in a compliant and inspection-ready manner.

Neuheit Research is supported by a highly experienced team of Clinical Research Associates (CRAs) who manage on-site, remote, and hybrid monitoring activities with a strong focus on participant safety, protocol adherence, and data quality. Each project is supported through a customized operational strategy, developed in close collaboration with sponsors to address study objectives, timelines, site capabilities, and regulatory expectations.

Our Clinical Operations function works in close integration with Regulatory Affairs and Quality Assurance teams, enabling proactive risk management, timely issue resolution, and continuous compliance oversight. Resources are allocated based on project scope and complexity, with well-defined communication pathways established across investigators, sites, and study stakeholders.