Creating the ideal Approach to gain Balance between effective Oversight and Micromanaging

Transcription

1 Creating the ideal Approach to gain Balance between effective Oversight and Micromanaging Karine Pigache-Renard and on behalf of Ulrike M. Grimm 4 th Annual Outsourcing in Clinical Trials Europe Conference, Arena International Brussels May 21/22, Galenica Group May 2014 VIFOR PHARMA, THE PHARMA BUSINESS SECTOR OF THE GALENICA GROUP

2 Sponsor-CRO: How to make a successful relationship How a service provider could make their interactions and meetings in the selection process more easy towards the sponsor : 1) Build contingency plans to prevent loss in continuity of study teams 2) Discuss control of potential vendor staff turnover at the beginning of the collaboration to minimize frustration experienced further down the line 3) Thorough assessment of your project team for experience, skills and fit to ensure a timely delivery 4) Use knowledge from CRO to work in collaboration with sponsor teams to build up a joined increased credibility and confidence 2 Galenica Group

3 Sponsor-CRO: How to make a successful relationship 5) Allow proposal review meeting to be as interactive as possible to ensure queries by sponsor are turned around in an appropriate timeframe 6) Include executive summaries in monthly reports highlighting strategy, key differentiators, costs and timelines to allow for insight into CRO's thought process 3 Galenica Group

4 Outsourcing Benefits - Offer a proven expertise from an external staff, - Easier and facilitated access to potential list of sites being previously involved in similar clinical trials - Bring flexibility in the Sponsor s resource management - Shorten timeframe to market new drugs 4 Galenica Group

5 Lifecycle Contract Management 5 Galenica Group

6 CRO Selection process Sponsor usually carries out an RFP process Contracts awarded after bid defense meetings Sponsor s due diligence should include: Web research and other reliable sources Thorough analysis of Responses to RFP Interviews with operational leaders Site visits 6 Galenica Group

7 Common Project Risks 7 Galenica Group

8 Common Project Risks Delays and quality issues from staff turnover Delays in getting regulatory approvals Delays in site initiation visits Delays with patient recruitment Difficulties with the management of clinical trial supplies Issues with vendors Delays with the processing of CRFs and solving queries 8 Galenica Group

9 CRO Selection process Sponsor usually carries out an RFP process Contracts awarded after bid defense meetings Sponsor s due diligence should include: Web research and other reliable sources Thorough analysis of Responses to RFP Interviews with operational leaders Site visits 9 Galenica Group

10 Risk Assessment Plan RISK ASSESSMENT: Assessment of risk associated with proposed patient population feasibility with # of sites? Dose (vs label) Probability of success / endpoint / statistics Label change intended? Any other risks Copyright Vifor Pharma,

11 Ground Rules in Study Management Suit CRO selections based on specific needs of each trial Set up realistic and clear objectives Gauge internal capabilities and advise the other party accordingly Define budget allocated upfront Establish clear lines of communications between parties through a communication plan including issue management Build up trust, openess and confidence across the Sponsor-CRO relationship 11 Galenica Group

12 Communication Plan: Functional Area Communication and Escalation Pathways Subject matters Project Management: Overall responsibility on delivery of study, coordination of activities, study timelines; study quality & quality issues, patient recruitment, essential documents,, study specific training & SOPs, site issue escalation, overall study budget, training Regulatory Affairs: Preparation of documents (e.g., IB, PTC, ICF, other) Primary Contact Person Vifor Pharma To: CTM Cc: CTA, <<name of study mailbox>> To: RA Manager Cc: CTM Cc: <<name of study mailbox>> GENERAL Primary Contact Person CRO/vendor To: Please Specify Role rather than name in order to avoid the need to up-date when a person changes on the study. Cc: To: Cc:, Escalation Contact Person Vifor Pharma To: Head Global Clinical Operations Cc: Clinical Outsourcing Manager To: Group Lead Regulatory Affairs Cc: Head Global Clinical Operations Investigational Medicinal Product Supplies: label(s), IMP import To: CSM Cc: RA Manager; CQA manager, CTM Cc: <<name of study mailbox>> To: Cc:, To: Head Global Clinical Operations Pharmacovigilance: SAEs and safety related issues To: Drug Safety Manager Cc: CRM, CTM Cc: <<name of study mailbox>> To: Cc: To: Head Global Drug Safety Cc: Head Global Clinical Operations Data Management, data cleaning To: DM Cc: CTM Cc: <<name of study mailbox>> To: Cc: To: Head Global Biometrics & Data Management Cc: Head Global Clinical Research, Head Global Clinical Operations Statistics To: Stat Cc: CTM Cc: <<name of study mailbox>> To: Cc: To: Head Global Biometrics & Data Management Cc: Head Global Clinical Research, Head Global Clinical Operations

13 Communication Plan: Escalation Process Copyright Vifor Pharma,

14 Tools for Escalation Agenda 3 days before the meeting and Minutes 3 days after the meeting Action Item Tracker indicating who does what until when Issue Tracker with rules when to report what issues, in addition response timelines are essential Copyright Vifor Pharma,

15 Study Management Plans Identify risks and their management/contingency plan beforehand Establish a management plan to describe clearly how the procurement processes will be dealt with throughout the life cycle of your contract Integrate the various plans (communication, risks & contingency, procurement, recruitment, ) into the PROJECT PLAN, that will become the primary source of information for how the study will be executed, monitored and closed 15 Galenica Group

16 Recruitment Plan RECRUITMENT FEASIBILITY : # Patients # S it e s FPFV (mm.yyyy) LPFV (mm.yyyy) LPLV (mm.yyyy) CSR (mm.yyyy) Pats/site/ month Anticipated participating countries: Study design feasibility / operations: incl. Study medication Timeline feasibility: Copyright Vifor Pharma,

17 Define & agree Metrics as Key Performance Indicators during Study Startup to achieve the following Objectives Create alignment and focus Assess and manage issues Inspire/motivate people Learn lessons regarding what works Maximize data quality Ensure timelines Gauge performance against benchmarks 17 Galenica Group

18 Benchmarks for Clinical Studies* Project approval Synopsis approved Final study protocol 1 st submission 1 st site initiated FPFV LPLV DBL Final study report 16 weeks 10 weeks 7 weeks 16 weeks 1-2 weeks Study specific 9 weeks 27 weeks * Median time periods based on data from CMR / Thomson Reuters Copyright Vifor Pharma,

19 Metrics/KPIs for a Dashboard Allow a comparison between sites for: -Subjects (overall randomization, monthly rate, screen failure, dropout rate) -Start up (contract completion time, document completion time) - Data (query rate, query completion time) -Expenditures (overall cost per patient, advertising cost per patient) 19 Galenica Group

20 Dashboard (1) Study Start-up Study Number of initiated sites versus plan Number of initiated sites / total number of sites Number of site contracts executed versus plan Number of contracts longer at site than XX days Copyright Vifor Pharma,

21 Dashboard (2) Study Conduct Study Actual versus expected Screen Failure Rate Randomized patients: actual versus plan % of delayed Monitoring Visit Reports Copyright Vifor Pharma,

22 Dashboard (3) Study Evaluation Study Number of sites with queries longer than XX days Medical Number of Review Plan cleaned patients on track Copyright Vifor Pharma,

23 Dashboard (4) Finance Issues Study Budget on track Comments Copyright Vifor Pharma,

24 Issue tracker Copyright Vifor Pharma,

25 Manage Staff Sponsor should approve any additional or replacement in CRO s staff throughout the study Sponsor access to CRO team training records Consider specifying training requirements for the CRO team, including any replacement personnel Training of replacement personnel should be allocated to the CRO 25 Galenica Group

26 Monitor your Project/ Study Ensure sponsor oversight by: Request of periodic reports of progress/milestones Gauge the performance by comparison to benchmarks Use the dashboard KPIs for regular assessment of progress Give feedback frequently Escalate issues when it deemed necessary Update your project plan 26 Galenica Group

27 Conclusion-Take away In-depth planning: timelines, cost, quality, resources, communication, risks - Set up a realistic schedule based on resource availability and durations - Develop the budget, contingency, recruitment, communication and risk plans - Integrate and coordinate all these plans into a standalone PROJECT PLAN which will be executed by the team to achieve goals. Monitor and control: - Track, review and regulate the progress and the performance against baselines in using KPI, metrics, dashboards. - Manage changes through a established control process (Issue tracker..) - Update your PROJECT PLAN - Escalate issues as soon as they arise Close your study through gathering lessons learns 27 Galenica Group

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