Meeting sponsor s criteria : strategy to collaborate, engage and deliver

Transcription

1 Meeting sponsor s criteria : strategy to collaborate, engage and deliver Frédérique Couttet Clinical Trial Manager 4th Annual Outsourcing in Clinical Trials Europe Brussels, Switzerland, May 21 22, 2014

2 Meeting sponsor s criteria : strategy to collaborate, engage and deliver 1. Characterizing the size of a company to understand needs and expectations 2. Using separate feasibility team to assess and discuss realistic timeframes during RFP 3. Clarifying every step to encourage transparency and strengthen relationships 4. Comparing SOPs and discussing disparities for a clear start-up phase 5. How developing the right contract can prevent disputes between Sponsor and CROs 6. Importance of contract management on both sides to tackle issues that arise 2

3 1. Characterizing the size of a company to understand needs and expectations 3

4 Differences between large and small pharmaceuticals companies Domains Large Small Main Activity Pipeline Research, development, marketing and sales Extensive, many therapeutic fields Presence Worldwide Local Staff, processes Comprehensive, many support services Mainly research and/or development Highly specialised, few products Minimum dedicated to core activities, multitasked Decision making Complex, administrative Simple, quick, flexible Working environment, visibility Budget size and availability Study teams responsibilities Secure, room for margins, long term Large, available if necessary Several different studies / products Investors pressure, low or no margins, short term Limited, weight for all tasks Dedicated to 1 or 2 studies 4

5 Needs depending on company size Large Pharma / Biotech Improve development efficiency and time to market: Cost reductions Improved quality Innovative technology Increase development on emerging markets Regulatory assistance in emergent countries Mitigate risks of fluctuations of activity Gain flexibility and speed in operational processes Small Pharma / Biotech Acquire capabilities to develop their products on limited time periods: Standardised processes Qualified Resources High level equipment & facilities Expert operational & regulatory knowledge Access to foreign countries Access to expert sites Get detailed knowledge of study progress Be alerted on any little issues (risks of delays, costs changes) 5

6 Expectations depending on company size Large Pharma / Biotech Deal with high level supervision Small Pharma / Biotech Deal with close supervision, flexibility Manage wide range of services Improve efficiency of sponsor s staff Improve operational processes Stay committed throughout the trial Alert Sponsor in advance on any little issues Provide operational guidance 6

7 Sponsors common expectations Value, Quality, Guidance and Satisfaction Holistic and accurate reporting of study progress Transparency on the management of their studies Communication adapted to sponsor s culture Alerted ahead of time on issues affecting timelines, budget, quality Adequate resources maintained throughout the trial CRO team available & committed Issues analysed and solutions proposed Flexibility for little changes Promises achieved 7

8 2. Using separate feasibility team to assess and discuss realistic timeframes during RFP 8

9 Objectives of feasibility studies: different for Sponsors and CROs Sponsor s objectives Define scope of work in order to develop precise RFP Identify risks, evaluate needs for changes, define realistic timeframe Evaluate partner s potential to match outsourcing needs Develop contract easily and quickly adapted from RFP CRO s objectives Identify risks, evaluate needs for changes, assess planned timeframes Suggest changes to get more control Identify where and how much benefit can be made Build a proposal to win the project Selection Process Assess scope of Request For Proposal, Bidding process Several Service Providers proposals reviewed Expectations meeting / Face to Face meeting 9

10 Different options for conducting feasibility studies Done by Sponsor for small studies Pro s: Access to experts, networks and patient advocacy groups Cont s: Local, specific therapeutic area, no access to powerful databases Part of proposal process Pro s: Free but risk of biased proposal with under or over estimated work Cont s: Not fully reliable due to time constraints Reliable if relationships exist between Sponsor and CRO long ahead of RFP Included in CRO contract Pro s: Risk of biased proposal with under or over estimated work Cont s: Normally in line with what CRO will execute. Risks are shared Done ahead of time by a different company 10

11 Using separate feasibility team Advantages for Sponsor Unbiased assessment Objective advice on conduct and suggestions for changes Clear project and expectations to build RFP Standard to compare proposals and for identifying over/under estimated work Down sides for Sponsor Less control given to CROs leading to less commitment and less risk sharing Expensive No engagement in the study conduct Plans could change with a different CRO conducting the study 11

12 3. Clarifying every step to encourage transparency and strengthen relationships 12

13 What is transparency? Transparency definition Making easy for others to see what actions are performed, foreseen Transparency implies: openness, communication and accountability Transparency tools User-friendly IT platform visible to all study members Reports on KPIs, issues, constraints affecting study progress Regular and structured communication pathways Feedback loops opportunities 13

14 Transparency achievements Save time by: Avoiding duplication of work, misunderstanding Improve quality & motivation by: Ensuring consistency in working processes Better matching of capabilities & expectations Enhancing team spirit Release pressure by: Mitigating risks quicker Sharing identity and decisions By implementing transparency in the project, relationships are strengthened and trust can be built 14

15 Clarifying every step to allow building trust Vendors needs: Clear & realistic expectations Responsiveness to enquiries High level team preparation and organisation Collaborative team environment Encourage Sponsor to: Provide clear role and responsibilities definitions Provide clear communication plan Agree on CRO s standard processes Share key documents, operational data, project goals Ask for vendor input on timelines and working plans Evaluate outputs instead of process used Not prioritise costs and timelines above quality 15

16 Clarifying every steps: examples Project Initiation Provide a clear & realistic proposal for which you can stand for Ex: Clarify how you evaluate the number of PM hours Project Planning Develop specifications, plans and guidelines avoiding making assumptions Ex: Monitoring Guidelines should mention specific countries requirements Project Execution Ensure team members fully understand their role and responsibilities, reporting lines, and impact on other people activities Ex: Provide RACI tables and picture of study team organization with communication pathways Project Control & Risk Management Agree on triggers for pre-identified risks and automatic escalation passes Ex: If 10 similar PDs arise, Medical monitor will automatically alert PM who will initiate retraining of staff and review of guidelines Project Review Re-Check consistency of plans with current environmental constraints Ex: Seasonal disease: Will sites be open in the right season, in the right countries? 16

17 4. Comparing SOPs and discussing disparities for a clear start-up phase 17

18 Importance of Standard Operating Procedures SOPs ICH-GCP definition: Written instructions to achieve uniformity of the performance of a specific function Importance of SOPs Manage compliance obligations Create operational efficiency Provide people accountability for defined tasks Train staff with consistency Key SOPs to be reviewed: Recruitment & retention, Protocol Deviations, AEs & SAEs Reporting, Drug Accountability and Management, Regulatory Document Submission Process, Monitoring Visits, Records keeping, Site selection & Contracting 18

19 Comparing SOPs and discussing disparities for a clear start-up phase Why reviewing and comparing SOPs Study team formed by people from different companies Ensure vendor s compliance with ICH-GCP Understand roles and responsibilities, company structure Possible disparities to be discussed Vendor s processes adequate for sponsor s study Accountability of team members consistent with vendor s commitment Non compliance assessment, Audits & Inspections handling Clarifying start-up phase: Choose SOPs allowing to efficiently achieve the study goal Increase trust in vendor s expertise, promises, quality of work 19

20 5. How developing the right contract can prevent disputes between Sponsor and CROs 20

21 Selecting the right contract structure Conditions and constraints to be assessed Overall project goal and priorities: performance, costs control, collaboration Precision of scope of work and risk assessment Expected amount and frequency of changes Time and level of expertise available to manage the contract Industry standards for different types, size, stage of delegated activities Different contract structures Fixed price / Work package based fixed price Detailed scope of work Controlled costs / average management effort Easy to adapt from proposal Risk of Change Orders Time and materials / Fees for service Scope of work not needed Final cost unknown / heavy management effort 21

22 Key elements to be addressed by PMs Definitions, scope of work, timelines, deliverables Roles and responsibilities Qualification and training requirements Quality requirements Processes, implementation of continuous improvement Pricing and payments payment schedule, performance bonds, price adjustments Risks Change request handling Relationship and Communication Frequency and format of metrics reporting, meetings, escalation processes Annexes (RACI tables, WBS, Project Plan, important templates, SOPs ) 22

23 CRO s acceptance for sharing the risks Risk sharing acceptance depends on CRO s control of the project Sponsor Clarity of Scope of work and Roles and responsibilities Level of Risk assessment performed by both parties Level of sponsor s acceptance of CRO s proposed changes Level of shared knowledge and transparency Level of operational responsibilities in vendor s hands 23

24 Efficiency of different risk sharing options Provider s financial interest in outcomes of studies Rare, limited to large companies, complex, not much information available Bonuses for achieving milestones / targets Common, mixed positive and negative, add stress but good for recognition Penalties for missing milestones / targets Used sometimes, negative impact, limit trust, use time and resources for negotiation, rarely applied due to sponsor s responsibilities often involved Guaranties for continued work / revenue Common, generally satisfactory to both sides, enhance trust and commitment 24

25 6. Importance of contract management on both sides to maintain trust and achieve success 25

26 Ensure oversight via regular review & discussions Governance of the project Changes and consequences Sponsor/CRO Relationships (responsiveness, issue resolution, transparency, alerts ) Efficiency of operating processes, manuals Roles and responsibilities (New personnel, sub-contractors, training & qualification) Quality achievements Audit schedules and CAPA logs Risk logs and validity of key risk indicators Significant and repeated deviations Budget status Review costs compared to deliverables (estimate to completion) Assess financial compliance 26

27 Trust and commitment are key to Clinical Trial success Aiming to build trust at each steps will leverage the best of people, enhance commitment to fulfil promises and achieve project success and both teams satisfaction 27

28 Questions? Thank you 28

29 Back-up slides Feasibility assessments RACI table Satisfaction / Needs graph 29

30 Required feasibility assessments Incl./excl. criteria too restrictive? Number of AEs expected Patients concerns, needs Patients Adequate population, prescriptions Staff qualification, availability, training Contract requirements and timelines IECs requirements and timelines Sites Other competing studies Type of sites, countries Standard of care compatible with protocol Regulatory requirements & timelines Timeframe from feasibility to 1 st site open Environment 30

31 Required feasibility assessments Design achieving scientific & strategic goal? Acceptable for RAs, IECs, motivating for PIs? Number of changes required Timeframe from feasibility to final protocol Protocol Planned costs, resources, timelines Study team structure, other partners Facilities and equipment Performance metrics, reports IT platforms, communication Organisation Risks affecting costs, quality and timelines KRIs, Triggers Mitigation plans with responsibilities Risks 31

32 Understanding responsibilities using RACI table Study Budget Tracking CRA Training DATA Management & Validation Plans Investigators Meeting CTM A, R A C, I A CRO PM C R C R DM C C A, R R Head of ClinOps I I I C 32

33 Fusszeile 33