AH&R Team Expertise

We provide specialized support throughout every stage of your clinical trial, from planning to final report

Clinical Site Management

Our Clinical Site Management services ensure efficient trial operations, regulatory compliance, and optimal site performance. We handle every detail with precision to support your clinical trial's success.

Site Staffing

We provide qualified, experienced clinical staff tailored to the needs of your study. From clinical research coordinators to site managers, our team ensures the right people are in place to drive study success.

Study Coordination

Our study coordinators manage the daily operations of your clinical trials. They oversee patient recruitment, scheduling, data collection, and more, ensuring smooth execution and adherence to timelines.

Regulatory Compliance

We handle all regulatory aspects of your clinical trial, ensuring strict adherence to GCP, NDCT Rule 2019, FDA, and all ethical and international standards.

Patient Recruitment and Retention

We focus on recruiting the right patients for your trial through targeted outreach and strategic partnerships, ensuring a steady flow of qualified participants with minimal drop-out rates.

Quality Assurance and Monitoring

Our team conducts ongoing monitoring to ensure the trial adheres to the highest quality standards and regulatory requirements through regular site visits, audits, and compliance checks.

Data Management & Reporting

We handle all aspects of clinical trial data—collection, validation, and analysis ensuring that it is accurate, secure, and compliant with industry standards.

Training Services

We offer customized training programs for clinical trial staff including training on GCP and regulatory guidelines, safety protocols, and other key aspects of clinical trials.

Comprehensive Service Portfolio

Our expertise covers every aspect of clinical trial management

Core Services

  • Development of trial site with quality assurance and compliance with regulatory
  • Development of site SOP
  • Training on GCP and regulatory guidelines related to clinical research
  • Site Recruitment and Feasibility Assessment
  • Study Site Management
  • Regulatory Compliance and Documentation
  • Clinical Trial Data Management for Phase 1 to Phase 4 and BA/BE Studies
  • Observational studies including Analytical and Descriptive studies
  • Patient Recruitment and Retention
  • Study Documentation in compliance with ALCOA++ and Reporting
  • Financial and Contract Management

Specialized Services

  • Quality Assurance and Risk Management
  • Online SAE Reporting on Sugam portal and SAE management
  • Study Close-Out
  • Other services (Laboratory support, Imaging services)
  • Online EC registration and re-registration under CDSCO via Sugam portal
  • Development of EC SOP and regulatory documents
  • Essential document audits
  • Investigational Drug Management
  • Review of the in-house documents to prepare for inspection
  • Inspection readiness visits to CRO and Investigator sites
  • Communication with stakeholders (Ethics Committee, Regulatory affairs and Institution)

Our Service Process

How we deliver exceptional results for your clinical trials

Assessment

We evaluate your trial requirements, site capabilities, and regulatory needs to develop a comprehensive management strategy.

Planning

Detailed planning phase including site setup, staff training, regulatory documentation, and timeline development.

Implementation

Execution of the clinical trial with ongoing monitoring, patient recruitment, data collection, and quality assurance.

Monitoring & Reporting

Continuous monitoring of trial progress with regular reporting to sponsors and regulatory compliance maintenance.

Study Close-out

Comprehensive study closure including final data validation, regulatory submissions, and site closure activities.

Scope of SMO Services

Optimize Site Management

From patient recruitment to trial close-out, ensuring compliance and data integrity throughout the process.

Enhance Site Efficiency

Supporting regulatory submissions, staff training, and seamless trial operations for maximum efficiency.

Drive Clinical Trial Success

Through effective site selection, monitoring, and regulatory compliance ensuring successful outcomes.

Future Expansion

Next Step of organization is arrangement of Clinical Research Training Program & placement, dedicated to empowering PharmD, M Pharmacy, B Pharmacy, degree in medical background & paramedical courses students with industry related skills and practical knowledge from sites.

  • Ensure smooth trial execution by managing site logistics, data quality, and patient engagement
  • Support investigator sites with expert management, compliance, and patient retention
  • Comprehensive training programs for clinical trial professionals
  • Industry placement support for qualified candidates

Ready to Experience Our Excellence?

Contact us to learn how our comprehensive services can streamline your clinical trials and deliver exceptional results.