Ensuring Compliance with ProPharma's Expert Support
The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the increasing complexity of clinical research.
The recent revision from ICH E6 (R2) to ICH E6 (R3) marks a significant step toward modernizing Good Clinical Practice (GCP) guidelines, emphasizing flexibility, patient-centricity, and risk-based approaches to quality management.
At ProPharma, navigating these changes can be challenging for sponsors, CROs, and investigator sites.
Our comprehensive suite of GxP compliance and clinical quality services ensures that our clients in the pharmaceutical, medical device, biologic, and advanced therapy industries remain fully aligned with regulatory expectations.
From global GxP auditing to clinical inspection readiness, we provide tailored solutions to support compliance with the updated ICH E6 (R3) framework.
Key Revisions in ICH E6 (R3):
ICH E6 (R3) builds upon the foundations laid by ICH E6 (R2) while introducing refinements that enhance clinical trial quality, efficiency, and oversight. Below is a summary of the most significant changes:
Challenges Organizations May Face
Transitioning to ICH E6 (R3) poses several challenges for organizations, particularly those with established clinical trial processes that may not align with the updated principles. The shift toward risk-based quality management and decentralized trials requires significant changes in trial oversight, data integrity measures, and stakeholder collaboration. Additionally, organizations may struggle with integrating digital technologies and adapting to new regulatory expectations. Ensuring proper investigator oversight while managing an increasingly complex clinical trial ecosystem demands enhanced training, updated Standard Operating Procedures (SOPs), and strategic risk mitigation planning. Organizations risk delays in trial approvals, increased regulatory scrutiny, and potential noncompliance findings without a structured approach to compliance.
How ProPharma supports Compliance with ICH E6 (R3)
Adapting to these changes requires strategic planning, risk assessment, and expert guidance. ProPharma offers a wide array of services to help organizations achieve and maintain compliance with ICH E6 (R3):
- Global GxP Auditing & Compliance Support: Our comprehensive global auditing services ensure adherence to new requirements across all GxP-regulated environments.
- Clinical Quality Systems Development: Assess, revise, and implement robust quality management systems that align with the latest risk-based principles right-sized for your organizational needs.
- Pharmacovigilance & Safety Support: We assist with full departmental PV and MI AE/SAE/Inquiry or Complaint Intake support to compliance oversight of service providers, digital media, and license partners.
- CRO and Investigator Site Readiness Assessments: Evaluate and enhance sponsor oversight and regulatory inspections readiness.
- Inspection Readiness & Mock Inspections: To mitigate risks, prepare your teams with targeted readiness assessments and mock inspections.
- Qualified Person (QP)/Responsible Person (RP)/Qualified Person for Pharmacovigilance (QPPV) Support: Access expert guidance in meeting complex regulatory requirements for product safety and distribution.
- Decentralized and Digital Trial Implementation: Adapt clinical trial operations to integrate decentralized methodologies and digital health technologies seamlessly.
- Regulatory Support: Ensure compliance with evolving regulatory requirements through expert consultation and strategic planning.
Partner with ProPharma for Seamless ICH E6 (R3) Implementation
The transition to ICH E6 (R3) presents a valuable opportunity to enhance clinical trial quality, efficiency, and compliance. With ProPharma's expertise, you can confidently navigate these changes, ensuring that your clinical programs remain inspection-ready and aligned with evolving global expectations.
Let us help you optimize your clinical quality and compliance strategy. Contact ProPharma today to learn how we can support your organization in achieving ICH E6 (R3) compliance and beyond.
Expertise and Support: ProPharma is your international, independent, single-source partner for expert insights pertaining to technical, quality compliance, and regulatory assistance throughout the product lifecycle. With over 2,500 employees, we have one of the largest compliance consulting groups in the world. When you partner with ProPharma, you gain the experience of the entire company—not just the team assigned to your project.
Global Reach: With offices and auditors located worldwide, ProPharma offers the availability to execute audits across different GxP areas of interest globally, creating efficiencies in both time and money. We have a large team of experienced auditors, with different areas of expertise, language skills, and cultural orientation. All auditors are fluent in English and many of our auditors are also fluent in at least one other language.
Breadth of Expertise: Our consultants have extensive audit and operational experience in at least one GxP specialty (GMP, GDP, GVP, GCP, GLP, and/or IT/CSV) and often in multiple areas of expertise.
Inspection Readiness: We ensure that every step towards Inspection Readiness is carefully calibrated to your needs. Our method is backed by tangible tools and training programs developed from the ground up, tailored not just to your product but to your organization's unique scale and scope. This approach allows you to focus on running your business while we dedicate ourselves fully to your Inspection Readiness, making it our singular priority.
