Regulatory Affairs

Our 24-site clinical research network operates within an integrated framework of regulatory compliance, ethical oversight, scientific governance, and quality management, supporting the responsible conduct of clinical research across participating institutions.

The Regulatory Affairs framework is supported by established research infrastructure, registered Ethics Committees with DHR and CDSCO, Scientific Review Boards/Committees, controlled Standard Operating Procedures (SOPs), institutional policies, trained research teams, and structured quality systems.

At the core of our approach is the protection of the rights, safety, dignity, and well-being of research participants, together with the integrity, reliability, and scientific validity of clinical research.

Regulatory Affairs provides governance and oversight throughout the research lifecycle, supporting investigators and research teams in meeting applicable regulatory, ethical, scientific, institutional, and quality requirements from study evaluation and start-up through conduct, safety oversight, close-out, and archival.

Regulatory Affairs Framework

1. Regulatory Compliance & Oversight

We support the conduct of clinical research in accordance with applicable regulatory requirements and institutional policies.

Our regulatory framework encompasses:

• Assessment of applicable regulatory requirements
• Local Regulatory submissions and approvals, where applicable
• Maintenance of essential regulatory documentation
• Regulatory communication and coordination
• Oversight of study-specific regulatory requirements
• Tracking of approvals, amendments, notifications, and applicable reporting obligations
• Regulatory compliance throughout the study lifecycle
• Support for regulatory inspections and institutional reviews

2. Ethics & Research Participant Protection

Protection of research participants is a fundamental principle of our research governance framework.

Research conducted across the network is subject to appropriate independent ethical review and oversight in accordance with applicable requirements.

The framework supports:

• Review by registered Ethics Committees
• Independent evaluation of ethical considerations
• Informed consent and participant information processes
• Protection of participant rights, safety, privacy, and confidentiality
• Additional safeguards for vulnerable participants, where applicable
• Continuing ethical review
• Review of protocol amendments and relevant study changes
• Safety oversight and review of reportable events
• Management of participant concerns and grievances through established institutional mechanisms

3. Scientific Review & Research Integrity

Scientific quality is integral to ethically responsible clinical research.

Our Scientific Review Boards/Committees provide structured scientific evaluation, to assess the scientific validity and institutional feasibility of proposed research.

Scientific review may include assessment of:

• Scientific rationale and relevance
• Research objectives and endpoints
• Study design and methodology
• Statistical considerations
• Risk-benefit considerations
• Operational and institutional feasibility
• Participant population and recruitment considerations
• Investigator and site capabilities
• Overall scientific merit

Scientific and ethical reviews function within the defined institutional governance framework while maintaining their respective areas of responsibility.

4. Research Governance

Our network maintains a structured research governance framework designed to promote accountability, transparency, consistency, and responsible research conduct across participating sites.

Key elements include:

• Defined institutional governance structures through Fortis Research advisory committee
• Roles, responsibilities, and accountability
• Investigator and research-team responsibilities
• Regulatory and ethics documentation oversight
• Study authorization processes
• Conflict-of-interest management
• Research integrity
• Data confidentiality and appropriate information governance
• Documentation and record-retention requirements
• Oversight across the research lifecycle

5. Standard Operating Procedures & Controlled Documents

Clinical research activities are supported by a structured system of controlled Standard Operating Procedures, policies, guidelines, and associated documents.

The SOP framework addresses key areas of clinical research operations, including, as applicable:

• Study feasibility and start-up
• Regulatory and Ethics Committee submissions
• Scientific review
• Informed consent
• Study conduct
• Safety reporting and oversight
• Protocol deviations and non-compliance
• Investigational product management
• Essential document management
• Research data and source documentation
• Training and delegation of responsibilities
• Study close-out
• Record retention and archival

Document control processes support appropriate development, review, approval, version control, implementation, periodic review, and archival of controlled documents.

6. Quality Management & Compliance

Quality is embedded within our clinical research governance framework to support consistent research practices, participant protection, regulatory compliance, and data integrity across the network.

Our quality framework incorporates:

• Quality Management System
• Quality oversight and review
• Risk-based quality management
• Identification and management of non-conformances
• Root-cause analysis
• Corrective and Preventive Actions (CAPA)
• Training and competency management
• Process improvement
• Audit readiness
• Regulatory inspection preparedness
• Continuous quality improvement

This structured approach promotes a culture of quality, accountability, learning, and continuous improvement throughout the clinical research network.

7. Training & Regulatory Competency

Maintaining appropriately trained research teams is an important component of our regulatory and quality framework.

Our network supports role-appropriate training and competency development in areas such as:

• Good Clinical Practice
• Applicable regulatory requirements
• Research ethics and participant protection
• Protocol-specific requirements
• Informed consent
• Safety reporting
• Standard Operating Procedures
• Research documentation
• Data integrity and confidentiality
• Quality and compliance responsibilities

Training and competency requirements are managed through defined institutional processes.

8. Audit & Inspection Readiness

Participating sites are supported through structured processes designed to maintain readiness for sponsor audits, institutional quality reviews, Ethics Committee oversight, and regulatory inspections, as applicable.

This includes:

• Essential document readiness
• Regulatory documentation review
• Training documentation
• Study-file review
• Identification of compliance gaps
• CAPA management
• Inspection preparation and coordination
• Response and follow-up management

9. Regulatory Intelligence & Resources

Regulatory Affairs facilitates access to relevant regulatory information and supports awareness of evolving requirements that may affect clinical research activities.

This includes:

• Applicable regulations and guidance
• Regulatory notifications and updates
• Ethics and participant-protection requirements
• Clinical trial registration requirements
• Institutional regulatory communications
• Relevant regulatory resources and reference links

A dedicated Regulatory Updates area may also be maintained to communicate significant developments to investigators and research teams.

Our Commitment

We are committed to conducting high-quality, scientifically sound and ethically responsible clinical research through an integrated framework of regulatory compliance, independent ethical oversight, scientific review, participant protection, quality management, and continuous improvement across our 24-site research network.