Inspection-Ready IRT. Valarie Higgins President & Managing Director Almac Clinical Technologies.

Transcription

1 Inspection-Ready IRT Valarie Higgins President & Managing Director Almac Clinical Technologies

2 2 Biologics License Application and the IRT Provider IRT

3 3 Agenda Why is IRT Becoming an Interest to the Agency? Areas to Pay Special Attention Preparing for an Agency Audit Key Learnings from Personal Experience 11/5/2015

4 4 Background My Personal Experience - Support of three filings high profile compounds - Spent time in Bethesda at multiple meetings with The Agency and client addressing FDA concerns around trial conduct and control - Consulted with two other clients to avoid FDA concerns with filings - Hosted FDA audit of Almac 11/5/2015

5 5 What do you use your IRT for? 11/5/2015

6 6 Historical & Most Basic Uses of IRT IRT Randomization Inventory Management Patient resupply / Maintain the blind Patient Tracking 11/5/2015

7 7 Expanded Use of IRT Driven by the need to reduce risk, improve quality, facilitate complex study designs Reduce complexity through automation of critical decision making Reduces risk to patient safety Improves consistency of decision making Improves quality Enables more complex study designs Adaptive trial Multiple cohorts Control of mid study changes Complex dosing regimens 11/5/2015

8 8 Why is IRT becoming an interest to the FDA? The use of IRT today is well beyond traditional RTSM in more and more trials (randomization and trial supply management) IRT visibility to protocol deviations and study conduct concerns and the FDA expect this information to be used appropriately # of site errors causing mis-stratification or out of window visit completion # of mis-dispensations # of dosing errors Level of control of temperature sensitive supplies The FDA Recognizes that the use of IRT reduces common study errors - Reducing Risk to Patient Safety & Data Integrity

9 9 Areas to pay special attention to 11/5/2015

10 10 Study Drug Dispensing Errors DON T WAIT! Make sure your data is aligned and explainable on a consistent basis. - EDC - Drug Accountability Logs X IRT Make sure your data is aligned and explainable Don t wait until the end of the study to resolve these issues Leverage IRT data for monitoring effectiveness! (Risk Based Approach)

11 11 Changes to Randomization or Drug Assignment Data Ensure clear reasons for modification and that the process is consistently followed. Updates to drug status to make unavailable at site Updates to drug record to show the actual patient drug was DISPENSED to (dispensing errors) Incorrect entries to stratification data The best solution is to automate these actions within the IRT

12 12 Temperature Monitoring And Adjudication Workflow The FDA is interested in the overall supply management effectiveness. Create a document that shows the entire integrated process and controls that are in place. Be sure to: Highlight each system involved and each company s delegated responsibilities Include reports / data that are used to monitor effectiveness of process Identify trends or potential issues, and who is responsible for addressing the issues

13 13 Integrations that Drive Dosing or Randomization Integrations with other systems Error handling and timely import Ensure requirements are clear and understood by all parties complete workflow and how the data will be used

14 14 IRT Reports And Alerts Leverage the power of information from your IRT? Exertions & Misdispensations Site specific Country specific Overall Improved visibility of issues in real time Exposes issues sooner Expect plans to manage issues better

15 15 Ensuring Readiness & Success in Navigating the Audit 11/5/2015

16 16 Ensuring your vendor is prepared Ensure SOP in place for hosting an agency audit Pre-Audit /Inspection Scheduling and Coordination Audit / Inspection Execution Employee Conduct during Client Audits and Regulatory Agency Inspections Post Audit Inspection 11/5/2015

17 17 Key Regulatory Focus Areas CAPA and Incident Reporting Processes Do you have a solid process? 21CFR Part 11, change control over data. Are your systems and processes compliant? System Validation Is there a validation process in place? Is there evidence of validation? Can you report on trends across CAPAs? Can you report on changes with audit trail? Very high level on this process area Are you following through on your CAPAs in a timely manner? Clear explanation of why you would need to make a manual change to IRT data FDA has not been focused on software development processes or best practice

18 18 Establish a Common Pool of Knowledge Do not assume that the agency has a solid understanding of how IRT is leveraged in today s trials Supply assignments Provide an overview of how IRT is programmed to perform key functions Offer a short demo of the system, what it is used for (and more importantly, what it is not used for) Use of common terminology used by IRT vendors to describe features such as release of supplies or labeling, may cause confusion.

19 19 Roles & Responsibilities Provide a clear overview of roles & responsibilities related to IRT services (contract and requirements) Who is responsible for acting on trends seen in the reports related to site errors / temperature excursions, etc.? ensuring that the drug gets to the site correctly? For addressing sites who make numerous errors?

20 20 Partnering for Success Establish clear communications and escalation pathways for audit prep All data / reports / documents should go through a single person (different versions, etc. cause confusion) Have joint meetings daily, to review events of the day and actions / plans for the next day

21 Question? 11/5/2015