Making clinical research crystal clear

Pharmacovigilance Services

At Krystelis, we recognise the critical importance of monitoring and managing the safety of pharmaceutical products throughout their lifecycle. Our comprehensive pharmacovigilance (PV) services help pharmaceutical companies ensure patient safety, comply with global regulatory requirements, and maintain the integrity of their products. We offer end-to-end support, from adverse event case management to risk assessment and regulatory reporting. Our proactive and customised approach ensures that potential safety issues are identified and managed effectively, enabling our clients to focus on their core mission of delivering innovative therapies to patients worldwide.

Pharmacovigilance
National and International Clinical Trial Registry Services Icon

Individual Case Safety Report (ICSR) Processing and Submission

  • Case Intake and Triage: Efficient intake, triage, and processing of adverse event reports from various sources including clinical trials, post-marketing, literature, and spontaneous reports.
  • Case Processing: Comprehensive case processing including data entry, coding, narrative writing, and assessment of adverse events.
  • Quality Assurance: Rigorous quality checks and audits to ensure data accuracy and compliance with regulatory standards.

Medical Literature Monitoring Services

  • Regular Surveillance: Regular monitoring of both global (indexed) and local (non-indexed) literature databases to identify emerging safety signals.
  • Comprehensive Review: Developing and executing robust literature search strategies, including duplicate checks and quality reviews on identified cases, abstracts, and articles.
  • Regulatory Compliance: Ensuring timely documentation and integration of safety data into aggregate reports, PSURs/RMPs, aiding in benefit-risk assessments, and enhancing overall pharmacovigilance compliance.
Redaction and Anonymisation Services Icon

Risk Management Services

  • Risk Management Plans (RMPs): Development, implementation, and maintenance of comprehensive RMPs to drive safety throughout a product’s lifecycle.
  • Risk Evaluation & Mitigation Strategies (REMS): Design and execution of REMS programs tailored to specific product risks.
  • Benefit-Risk Assessment and Mitigation Strategies: Continuous assessment of the benefit-risk profile of products and implementing risk minimisation strategies, including communication plans and educational materials.
Plain language summary (PLS) services Icon

Aggregate Safety Reports Services

  • Periodic Safety Reports: Preparation and submission of periodic safety update reports (PSURs/PBRERs), development safety update reports (DSURs), and other aggregate reports.
  • Compliance Monitoring: Ensuring ongoing compliance with all regulatory reporting obligations and timelines.

Pharmacovigilance Audits and Inspection

  • Global PV Compliance: Ensuring adherence to international pharmacovigilance regulations (FDA, EMA, MHRA, etc.).
  • Inspection Readiness: Preparing for regulatory audits and inspections with mock audits and gap analysis.

Pharmacovigilance Signal Management Services

  • Signal Detection: Continuous monitoring and detection of potential safety signals using appropriate data analytics and statistical methods.
  • Signal Evaluation: In-depth analysis and evaluation of detected signals to determine their clinical significance and potential impact.
  • Risk Assessment and Management: Proactive risk assessment and management plans to mitigate identified risks.

Advantages of using Krystelis Pharmacovigilance Services

Expertise and Experience

Our team of seasoned pharmacovigilance experts brings extensive experience and deep knowledge of global regulatory requirements.

Compliance and Accuracy

Rigorous quality assurance processes ensure compliance with regulatory standards and accuracy of safety data.

Efficiency and Timeliness

Streamlined processes enhance efficiency and ensure timely reporting.

Comprehensive Support

End-to-end pharmacovigilance services covering the entire product lifecycle, from clinical development to post-market surveillance.

Proactive Risk Management

Proactive identification and management of safety risks to protect patients and support regulatory compliance.

Customised Solutions

Tailored pharmacovigilance solutions to meet the unique needs of each client and product.

Partnering with Krystelis for pharmacovigilance services ensures robust safety monitoring, effective risk management, and compliance with global regulatory requirements, allowing pharmaceutical companies to focus on their core mission of developing life-saving therapies.
CTA-Bg-Shape-Orange
INTERESTED IN LEARNING MORE?

Get In Touch

CONTACT US
CTA-Bg-Shape-Blue