The Safety Case as a basis for more effective outsourcing of writing of aggregate safety reports

Transcription

1 The Safety Case as a basis for more effective outsourcing of writing of aggregate safety reports Dr Brian Edwards Scientific Adviser, Pharmacovigilance & Drug Safety, NDA Regulatory Science Ltd DIA 3rd Annual Clinical Forum October 2009 Nice Acropolis, Nice, France Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2

2 Where are the main geographical areas for BPO? In 2006, U.S. companies (all types) outsourced over 130,000 jobs, moving many of these jobs offshore. Projections indicate that this number will increase to more than 3.5 million U.S. jobs moving offshore by 2015 Main areas are: India, China, Eastern Europe, Brazil, the Philippines, Morocco, Egypt, and South Africa 3 Business process outsourcing (BPO): what are the options? Offshoring Traditional outsourcing in which a company is contracted far outside of the country of the original outsourcing company Nearshoring Offshoring in which a company is contracted outside of the originating company s country in a country that is close to the outsourcing company s country of business Subshoring When a company or organization hires staff in an offshore country to work directly for it 4

3 Where are the main areas for outsourcing in India? Three levels/types of service Business Process Outsourcing Contract Research Outsourcing Knowledge Process Outsourcing Ultimately are you comparing like with like when you look at proposals? 5 Where are the benefits for BPO for the sponsor? Transferring some of the risk associated with processes to the contracted company, while simultaneously realizing a substantial cost savings. The originating, outsourcing company can enjoy increased flexibility by investing less in certain areas of its business, which may not be its strongest thereby eliminating distractions and enabling a focus on its core business. The originating, outsourcing company to be more agile when market conditions demand organizational changes. For clinical research the primary attraction is generally subject availability. 6

4 What should be the aims of BPO? The originating organization and contracted offshore company to operate in an environment where both realize mutual benefits. In order for an outsourced or offshore partnership to work seamlessly, a certain amount of control must be given to the contracted outsourcer or offshore company. How often do you hear that Safety must be maintained? 7 Sponsor Point of View: Top Reasons that Change Orders are Typically Experienced Increase in scope of project that was not anticipated at the project start (74%) Project assumptions changed during the course of the project (70%) The CRO underestimated the effort it would take to complete this project (59%) CROs underbid the project intentionally in order to secure business (25%) Sponsor company teams sometimes do not manage to the specs of the agreement and/or request additional services not originally agreed on (23%) Sponsors do not articulate expectations clearly enough at the beginning of the project (16%) State of Clinical Outsourcing: Patricia Leuchten, President and CEO, The Avoca Group, Inc. June

5 Causes for negative experiences License to operate Asset reliability Quality issues Yes means, I will do whatever I can, No is culturally impolite Communication Issues So where are we with outsourcing? What do we really know? Outsourcing is increasing and will continue to do so in very different territories with varying approaches to risk, safety and regulations Main published experience lies with outsourcing of clinical trials but increasingly other activities including case management and writing of PSURs are included but no benchmarking in place Although individually companies may be doing their best, there is no industry consensus as to what is safe outsourcing or what due diligence should be performed. How can Qualified person for pharmacovigilance have oversight if there is no standardised process or agreed terms of reference There will always be an unknown proportion of vendors that will do anything to win the business: how can you distinguish good from bad apples? Ultimately: how do we know how to outsource safely? 10

6 The importance of the Human Factor Operational Learnings And I think what people miss is that business is about people. If you want to change the results of a business, you have to change how people operate, what they are doing, why they are doing it and what inspires them to do something differently. Carly Fiorina, former CEO of HP in an interview with Fred Vogelstein, 09 OCT Decisionmaking Human Function. Fluid. Leadership Cooperation Situational awareness PROCESS Regulations Solid. SOPs System Function. Quality systems Rules Methods

7 Humans - Software Procedures + SOPs Digital printouts Rules + Regulations S Human - Machine Switches; Info presentation; Instrument Layout MA HU HU Humans - Humans Team performance Professional culture Training E Academic Researchers Regulatory Authorities Industry + contractors Humans - Environment Organisational hierarchy Organisational climate Working Environment. Team working principles to deliver safe outsourcing DECISION MAKING SITUATIONAL AWARENESS LEADERSHIP COMMUNICATION ERROR MANAGEMENT PERSONALITY AND BEHAVIOUR

8 Sensitivity to Operations Closed Loop Communications Information Exchange Shared Situation Awareness Commitment to Resilience Back-up Behavior Monitoring Shared Mental Model Deference to Expertise Assertiveness Collective Orientation Reluctance to Simplify Adaptability Flexibility - Planning Preoccupation with Failure Error Management Feedback Self-correction Source: Wilson K, Burke C, Priest H, Salas E. Promoting healthcare safety through training high reliability teams. Quality and Safety in Healthcare What is the Safety Case? Comprehensive risk management is built into each element of a process to help ensure that processes are safe Provides critical data to a pharmaceutical company in the selection of a CRO for potential outsourced business Provides assurances of adherence to safety provisions via a standardized approach Would also level the playing field for prospective vendors

9 The Safety Case: combines value for money AND Safety The aim is by better comparing apples and apples we can more fairly and safely outsource: What is the Safety Case? A documented body of evidence that provides a convincing and valid argument that a system is adequately safe for a given application in a given environment

10 What is a Safety Case? Explicit safety cases are required for military systems, the off shore oil industry, rail transport and the nuclear industry. In the U.K.Statutory Instrument 2005 No The Offshore Installations (Safety Case) Regulations 2005 What is the Safety Case? The Facility description is the intended scope of operations of the facility, including the physical aspects, activities, and personnel of all of the sites. A high-level description of the safety management system, which must document that appropriate structures and processes are in place to facilitate improvements. The formal safety assessment is the systematic risk assessment of compliance failures, how errors are managed, root causes analysed, corrective and preventive actions implemented

11 The facility description Sites: where will work be done? Design and operation: how will work be done and by whom? Justification for why it is set up this way Description of the safety management system 1. Features of arrangements for medical writing Policy and objectives Planning and project risk assessment Implementation Monitoring, quality control and evaluation Audit and review Continuous improvement 2. Optimal evaluation Internal and external audit Measured against performance standards 3. Quality assurance of documentation 4. Emergency plans 5. Personnel

12 Description of the safety management system cont d 7. Equipment reliability 8. Safety management from sub-contractors, on-site visitation of personnel and guests, 9. Communications systems 10. Management of change 11. Permit to work situations 12. Drug, alcohol and related HR policies 13. Workforce health Description of Formal Safety Assessment Formal Safety Assessment 1. Rank hazards by consequence 2. Hazard analysis (circumstances, probability, impact, and consequence for all operations/activities and other hazards) 3. Range of controls (elimination, prevention, reduction in consequence, mitigation of consequences): defence in depth 4. Measures for protection 5. Human error (unintentional and intentional) 6. Organizational error 7. Hazard identification

13 How to apply the Safety Case to Medical Writing Projects? What about individual contract medical writers? - They must be integrated into the sponsor s team as they do not work in a system Safety case is applicable to companies to whom you are giving considerable responsibility - Does not remove need for supervision and sponsor accountability Next steps? ACRO: Benchmarking group