Clinical Research Services at Anweshan: A Full-Spectrum CRO in Nepal

Anweshan is Nepal’s pioneering Clinical Research Organization (CRO), providing comprehensive services across the clinical research lifecycle — from study design and regulatory clearance to trial implementation, data management, and quality assurance. With Nepal’s growing role in regional health research, we support sponsors, investigators, and health institutions in conducting ethical, scientifically robust, and locally relevant clinical studies.

 

1. Regulatory and Ethical Compliance

Clinical research in Nepal is regulated primarily by the Nepal Health Research Council (NHRC) and the Department of Drug Administration (DDA). As a CRO, Anweshan navigates and manages these regulatory processes on behalf of its partners to ensure full compliance:

• NHRC Ethical Approval
  We prepare and submit complete research protocols, informed consent forms, data collection tools, and Gantt charts to NHRC for ethical approval. Our team ensures that study documents align with NHRC guidelines on biomedical and public health research ethics.

• DDA Clinical Trial Registration
  For interventional drug trials, we support the registration process with the Department of Drug Administration, which includes submission of trial protocols, investigator brochures, IMP-related documents, and adverse event management plans.

• Local Site and Institutional Permissions
  We obtain necessary site approvals from hospitals, research centres, or community-level implementing bodies, including coordination with Institutional Review Boards (IRBs) where applicable.

 

2. Study Design and Feasibility Assessment

We work closely with sponsors and principal investigators to:

• Conduct feasibility assessments and site selection based on population characteristics, infrastructure, and regulatory conditions.

• Draft or refine clinical trial protocols, including inclusion/exclusion criteria, randomisation procedures, and data monitoring plans.

• Provide guidance on localisation of instruments and informed consent documents, including translations and cultural adaptations.

 

3. Clinical Trial Operations and Site Management

Anweshan supports the operational aspects of clinical research across different phases (I–IV) and types of studies:

• Site Initiation and Training
  We facilitate training of investigators, site coordinators, and data collectors in GCP, protocol adherence, and patient safety.

• Participant Recruitment and Retention
  Our team handles community engagement, outreach, screening, and informed consent processes, while ensuring participant confidentiality and retention strategies.

• Trial Monitoring and Quality Oversight
  We provide continuous site monitoring to assess protocol compliance, data quality, and participant safety. Monitoring includes both on-site and remote methods, supported by SOPs and digital tools for documentation and reporting.

 

4. Data Management and Statistical Services

Anweshan offers secure, compliant, and high-integrity data solutions:

• Development of case report forms (CRFs) and electronic data capture (EDC) systems

• Data entry, cleaning, and validation

• Real-time query management and issue resolution

• Biostatistical analysis and clinical study reporting

 

5. Pharmacovigilance and Safety Monitoring

We establish adverse event (AE) and serious adverse event (SAE) reporting protocols aligned with DDA and international standards. This includes:

• Training on AE/SAE identification and reporting

• Establishment of Data Safety Monitoring Boards (DSMBs) if required

• Ongoing risk-benefit analysis throughout the trial period

 

6. Quality Assurance and GCP Compliance

Our QA team ensures adherence to Good Clinical Practice (GCP) and local ethical regulations through:

• Regular internal audits and quality checks

• SOP development for trial procedures

• Corrective and preventive action (CAPA) planning

• Comprehensive trial master file (TMF) documentation and archiving

 

7. Post-Trial Access and Knowledge Sharing

We support investigators in post-trial data dissemination, policy translation, and stakeholder engagement. This includes:

• Manuscript preparation and publication support

• Results sharing with communities and stakeholders in alignment with NHRC guidance

• Assistance in scaling up interventions, if proven effective