Compliance & Quality Standards

Adhering to the highest industry standards for clinical trial operations

Our Commitment to Compliance

At AH&R, we are fully committed to adhering to the highest industry standards for clinical trial operations

Compliance is not just a requirement for us—it's the foundation of everything we do. Our comprehensive compliance framework ensures that every clinical trial we manage meets or exceeds all applicable regulatory standards, protecting participant safety and ensuring data integrity.

Our team stays current with evolving regulations and maintains rigorous quality control processes throughout every phase of clinical trial management.

Quality First Approach

We prioritize patient safety, comfort, and well-being throughout every trial phase, ensuring that their health remains the top concern while maintaining the highest standards of data quality and regulatory compliance.

Regulatory Standards We Follow

Comprehensive adherence to international and local regulatory requirements

Good Clinical Practice (GCP)

We follow GCP guidelines to ensure the ethical and scientific quality of clinical trials, prioritizing participant safety, data integrity, and regulatory compliance in accordance with ICH-GCP standards.

Standard Operating Procedures (SOPs)

Our team operates according to a set of strict SOPs to ensure consistency, efficiency, and regulatory compliance across all aspects of clinical trial management.

NDCT Rule 2019

Full compliance with New Drugs and Clinical Trials Rules 2019, including regulatory submissions, safety reporting, and clinical trial conduct in India.

FDA Regulations

Adherence to US FDA regulations for clinical trials, including CFR Title 21 parts 50, 56, 312, and 314 for investigational drug studies and regulatory compliance.

EMA Guidelines

Compliance with European Medicines Agency guidelines and European Clinical Trials Regulation for multinational studies and global regulatory submissions.

CDSCO Requirements

Full compliance with Central Drugs Standard Control Organization requirements including Ethics Committee registration, clinical trial permissions, and safety reporting.

Quality Assurance Framework

Comprehensive quality management systems ensuring excellence in clinical trial conduct

Quality Control Measures

Data Integrity (ALCOA++)

Study documentation in compliance with ALCOA++ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.

Regular Monitoring

Ongoing site visits, source data verification, and protocol compliance monitoring to ensure quality throughout the study lifecycle.

Risk Management

Proactive identification, assessment, and mitigation of risks to study quality, participant safety, and data integrity.

Audit & Inspection Readiness

Essential Document Management

Comprehensive Trial Master File maintenance and essential document audits to ensure inspection readiness at all times.

Inspection Readiness Visits

Regular inspection readiness visits to CRO and Investigator sites to ensure compliance and preparedness for regulatory inspections.

Audit Track Record

Successful experience with US FDA audits, QA audits, and Sponsor audits demonstrating our commitment to quality and compliance.

Safety Monitoring & Reporting

Comprehensive safety monitoring and adverse event reporting systems

SAE Management

Online SAE reporting on Sugam portal and comprehensive SAE management as per regulatory guidelines with 24-hour reporting capabilities and proper documentation.

Safety Monitoring

Continuous safety monitoring throughout the study with real-time assessment of adverse events, safety signals, and risk-benefit evaluation.

Ethics Committee Management

Online EC registration and re-registration under CDSCO via Sugam portal, development of EC SOPs, and ongoing ethics committee communications.

Training & Competency Management

Ensuring all team members are properly trained and qualified

Mandatory Training Programs

  • Good Clinical Practice (GCP): ICH-GCP certification for all clinical staff
  • Regulatory Guidelines: Training on NDCT Rule 2019, FDA, and other applicable regulations
  • Safety Protocols: Adverse event reporting and safety monitoring procedures
  • Data Integrity: ALCOA++ principles and documentation standards
  • Protocol-Specific Training: Study-specific procedures and requirements

Continuous Education

We invest in continuous professional development to ensure our team stays current with evolving regulations and industry best practices.

  • Regular regulatory update sessions
  • Conference and workshop participation
  • Certification maintenance programs
  • Knowledge sharing sessions
  • External training partnerships
  • Competency assessments

Regulatory Communications & Stakeholder Management

Effective communication with all regulatory stakeholders

Ethics Committee Communications: Regular correspondence with Ethics Committees including protocol submissions, amendments, safety updates, and annual reports.

EC Management

Regulatory Affairs: Direct communication with CDSCO, FDA, and other regulatory authorities for submissions, queries, and compliance matters.

Regulatory Communications

Institutional Coordination: Ongoing communication with participating institutions for approvals, compliance monitoring, and administrative coordination.

Institutional Relations

Compliance Track Record

100%
Regulatory Compliance
0
Major Audit Findings
70+
Compliant Studies
24/7
Safety Monitoring

Our Quality Commitment

Patient Safety First

Patient safety, dignity, and wellbeing are our top priorities in every clinical trial we manage. We maintain rigorous safety monitoring and reporting protocols.

Data Quality Excellence

We ensure the highest standards of data quality and integrity through comprehensive quality control measures and ALCOA++ compliance.

Ethical Standards

We uphold the highest ethical standards in clinical research, ensuring informed consent, patient rights protection, and ethical conduct throughout.

Continuous Improvement

We are committed to continuous improvement in our compliance and quality systems through regular reviews, updates, and enhancement of our processes.

  • Regular SOP updates and revisions
  • Quality management system improvements
  • Technology adoption for better compliance
  • Feedback incorporation from audits and inspections
  • Industry best practice implementation
  • Regular compliance assessments

Trust Our Compliance Excellence

Partner with AH&R for clinical trials conducted with the highest standards of regulatory compliance, quality assurance, and patient safety.

Discuss Compliance Requirements Learn About Our Services