Quality, Regulatory & Pharmacovigilance

Quality

Our Quality services promote excellence in study conduct and data integrity through proactive oversight and continuous improvement.

Our services cover the following:

• Monitoring: We provide robust monitoring support, including site initiation, ongoing monitoring of clinical activities, drug accountability reviews, and study close-out activities for both regulated and non-regulated trials. Our monitors are trained and experienced in ensuring participant safety, protocol adherence, and data quality.
• Audits / Quality Reviews: Sponsors and Investigators may request independent audits and quality reviews to assess compliance with applicable legislation, guidelines, SOPs, and GCP standards. These reviews support readiness for inspection and reinforce quality assurance across study conduct.
• Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation
• Training Programmes: We provide tailored training to equip Investigators and site personnel with the knowledge needed to conduct studies compliantly:
  • CH-GCP Training: Comprehensive courses in line with ICH-Good Clinical Practice.

Regulatory Affairs

We ensure all research aligns with regulations and ethical standards to protect participants and guarantee data integrity.  Our Regulatory Affairs team offers expert guidance and submission services to navigate ethical and regulatory frameworks effectively:

• Study Planning: We advise on regulatory requirements during study design and early planning, helping align protocol strategy with applicable legislation.
• Regulatory Planning: Interacting with Competent Authority to seek advice on behalf of PI re prospective study/ trial.
• Regulatory Approval: Submitting Clinical Trial Applications
• Ethics Committee Approval: Submitting Application to Research Ethics Committees (REC) on behalf of PI for Clinical Trials and studies.
• Amendments: Our team manages regulatory updates and amendments, handling communications with the Competent Authorities and RECs to ensure timely compliance with all regulatory requirements

Pharmacovigilance

We provide a comprehensive pharmacovigilance service focused on detecting, assessing, understanding, and preventing adverse effects and other drug-related problems during clinical development, while ensuring regulatory compliance and safeguarding patient safety.

• Case management: Collecting, assessing, and processing individual adverse event reports to ensure the accuracy and completeness of safety data.
• Safety data management: Setting up and maintaining safety databases for the efficient collection and tracking of safety data throughout the trial.
• Regulatory reporting: Preparing and submitting required safety reports to regulatory authorities, such as the Development Safety Update Report (DSUR) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
• Signal detection: Monitoring safety data to identify potential new risks or safety signals that require further investigation.