Sponsors, CROs and all the Rest Disclaimer The views and opinions expressed in the following PowerPoint presentation represent the opinions of the author / speaker and should not be construed as the position of PAREXEL. 1
Recent Key Changes ICH E6 R2 The sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results. The sponsor should ensure oversight of any trial related duties and functions carried out on its behalf, including trial related duties and functions that are subcontracted to another party by the sponsor s contracted CRO(s). Data Integrity Detailed clarifications on regulatory Data Integrity Expectations Drivers SMAC Technology 2
Sponsor Challenges How to establish oversight over Involved Vendors (especially subcontractors)? Compliance of Technology Solutions? Data Integrity? Enforcing standards across all parties involved and across all Layers CRO/ Tech Supplier Challenges How to deal with multiple sponsors that all have: Different interpretations of the regulations? Individual standards and software preferences? Study Specific needs for Technology solutions? How to manage the complexity? 3
Regulate, inspect and approve Sponsor Sponsor Sponsor Outsourcing Audit Deliver Data Regulators Regulate and inspect Outsourcing Audit CRO Deliver Data Inspect, if needed Tech. Supplier Tech. Supplier Tech. Supplier Present and Future Challenges Medical Mobile Apps & Wearables Single Instance Multi Tenant Systems Rapid Development & Deployment End to End Data Integrity Adaptive Trial Design & Change Control Data Privacy & Protection 4
Validation Standards GAMP 5..can help to address this New GAMP GPG for GCP systems GAMP Data Integrity Layer Model 5
Medical Mobile Apps & Wearables Future Vision mobile has the capacity to revolutionize every step of the clinical trial process: recruitment, data capture, and analyzing study data Examples are: Collect Informed Consent via Mobile App Monitor and assess the physical activity status of subjects via movement sensors wirelessly connecting a pulse monitoring pad to a smartphone or tablet allowing patients to perform a self administered ECG Physiologic sensor incorporated into a medication pill wirelessly transmits information such as vital signs, body position, and verification of medication ingestion to an App. Medical Mobile Apps & Wearables When do they become regulated like Medical Device? When you have to say yes to one of these Questions: Is the Mobile App / Medical Device providing a primary display of data that is critical to the diagnosis, medical monitoring and/or treatment of the patient? Is the Mobile App / Medical Device controlling a device that is critical to the diagnosis, monitoring and/or treatment of the patient? 6
Single Instance Multi Tenant Systems VM Customer 1 VM Customer 2 VM Customer 3 VM Customer 4 Customer 1 Customer 2 Customer 3 Customer 4 APP APP APP APP APP OS OS OS OS OS Virtualization Software Customer 1 Customer 2 Customer 3 Customer 4 Customer 1 1 Customer 2 2 Customer 3 Customer 4 4 Infrastructure Infrastructure Single Instance Multi Tenant Systems SUPPORT MIST Multiple versions to support/maintain Higher development/deployment effort Tighter SLAs SIMT One version to support/maintain Reduced development/deployment effort Looser SLAs 7
Single Instance Multi Tenant Systems SECURITY MIST Separate instances Isolated Data Standard Software SIMT Single Instance Data Cohabitation Custom Software Single Instance Multi Tenant Systems FLEXIBILLITY MIST Upgrade by Choice Can be customized SIMT Dictated Upgrades Can be only configured 8
Single Instance Multi Tenant Systems PERFORMANCE MIST Single Customer can be impacted Customer Controlled Environment SIMT All Customers can be impacted Vendor Controlled Environment Rapid Development & Deployment (DevOps) DevOps aims at unifying software development (Dev) and software operation (Ops). DevOps strongly advocates automation and monitoring at all steps of software construction, from integration, testing, releasing to deployment and infrastructure management. DevOps aims at shorter development cycles, increased deployment frequency, more dependable releases, in close alignment with business objectives. (Some) Companies that practice DevOps have reported significant benefits, including: significantly shorter time to market, improved customer satisfaction, better product quality, more reliable releases, improved productivity and efficiency 9
Rapid Development & Deployment (DevOps) Fast release of new functionality out of agile development into production environments Pros Faster delivery of features Better support of business processes Cons requires higher automation (e.g. testing) requires a culture for quality Interfaced systems may be a challenge Frequent training may be needed End to End Data Integrity In connected platforms Within a Study over time Across organizations 10
Adaptive clinical trials Traditional Design: Poor information leads to poor performance Additional information collected during trial execution is not used Wrong assumptions are discovered late/at the end of the trial Adaptive trials attempt to use incremental information gained Various ways to achieve such a pathway Faster way to select the right drug/right patient group (seamless design) BUT: Challenges apply Sample size and future trial requirements not fully known Constant adaptation of the trial apparatus (design, execution, infrastructure) Adaptive clinical trials Drug A Drug A Drug A Drug B Drop t0 Drug C Control Drug C Control Interim Analyses Drop Control tn (years) Confirmation 11
Differing life cycles as a challenge Medium/Long Study Lifecycle Study design/size Medium Regulatory Lifecycle New regulations Long Drug Lifecycle From discovery to registration Short Technology Lifecycles E.g SIMT/MIST Rapid Development Change control in a complex landscape Regulate, inspect and approve Sponsor Outsourcin g Audit Sponsor Sponsor Delive r Data Regulators Regulate and inspect Outsourcin g Audit CRO Delive r Data Inspect, if needed Tech. Supplier Tech. Supplier Tech. Supplier 12
Data Privacy & Protection New regulations will become effective in the EU Will present us with new requirements, risks and controls in the validation How can the new GPG help in addressing this? The Layer Model supports the usage of IaaS, PaaS, SaaS etc., and defines handover points This concept would equally be supporting: Mobile Apps/ Wearables SIMT and DevOps Adaptive Trial Design The detailed guidance provided in the guide on Clinical Trail Processes and Data Integrity is also valuable in addressing these new challenges More publications (e.g. Case studies) are planed for the future 13
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