Inspection Readiness and Inspection Preparedness
At Clinical Pathways, we understand the importance of being prepared for regulatory inspections of the sponsor, CRO, and clinical investigator site. Preparing for regulatory inspections can be challenging and time consuming. Clinical Pathways offers comprehensive global inspection readiness consulting services tailored to our clients’ specific needs across the GxP. We promote a scalable, risk-based inspection readiness model that grows with the maturity level of the client.
Whether it is for a FDA BIMO or non-BIMO, EMA, or MHRA inspection, our services encompass a holistic approach, aiming to ensure that our clients are well-prepared and confident in their ability to speak to the regulatory authorities. Our team of experienced professionals provide expertise in global regulatory compliance, continuous quality improvement, and cross functional inspection readiness for GCP Clinical and Post-Marketing (REMS, PADER), GVP, GLP, and GMP PAI inspections.
Inspection Readiness increases awareness of areas that can be covered during inspections, and implementation should be considered at early stages. Key areas in which our consulting services can support organizations in achieving inspection readiness are:
Inspection Readiness Program Development: Our consulting services begin with an inspection readiness assessment and gap analysis. This phase helps develop a clear roadmap of the organization's path to inspection readiness based on identified risks. We work closely with teams to develop a plan that addresses identified gaps, establishes high risk topics and strategies for continual improvement, identifies the appropriate subject matter experts, analyzes existing inspection readiness tools, and sets timelines for implementation.
Training and Education: We offer tailored training programs to enhance the knowledge and skills of staff involved in regulatory inspections. Our training covers topics such as staff responsibilities during inspections, inspection etiquette, communication strategies, and effective responses to inspection findings. By enhancing your staff's knowledge and understanding of regulatory expectations, we empower them to confidently navigate an inspection.
Inpection Readiness Meetings: Following the assessment, we work with cross functional subject matter experts (SMEs) to knowledge map and storyboard the identified topics for the studies that support the regulatory application. The process often identifies gaps in documentation, processes, or knowledge. This enables organizations to proactively identify and address any gaps before an inspection occurs.
Strategy and Mini Mock Sessions: Prior to mock inspection, team training exercises, strategy meetings, and mini mock sessions on specific identified high risk topics help subject matter experts learn to speak with confidence to the topics that really matter, including strategies on how to address gaps.
Mock Inspections: Our team supports our clients in preparation, participation, responses, and follow up actions for mock inspections. Mock inspections provide an opportunity for subject matter experts to become familiar with the inspection process, practice speaking to regulatory authorities, build confidence, and refine their responses. Support during Mock inspections includes front room, back room, SME Prep, and so on.
Continuous Quality Improvement: After an inspection, we support clients in instilling a culture of compliance throughout the organization. Our team supports the development of sustainable continuous improvement strategies to ensure long-term compliance and quality outcomes. We collaborate with clients to develop and implement robust quality management systems that streamline processes, foster proactive risk identification, support continuous inspection readiness, and drive ongoing staff training and education initiatives.
Post-Inspection Support: Our commitment to our clients extends beyond the inspection process. An ongoing process of maintaining inspection readiness, inspection preparedness can be difficult to navigate within the boundaries of the corporate culture. Our aim is to foster a culture of continuous improvement, where inspection preparedness becomes an established part of your organization's quality culture.
Sponsor Inspection Readiness includes:
Clinical Trials
FDA BIMO and non-BIMO Sponsor/CRO
FDA GMP PAI
UK/EMA
FDA BIMO Site/Investigator
Post-Marketing
FDA PADE Reporting
FDA REMS