OCTC 2012 CRO Selection

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1 OCTC 2012 CRO Selection Colin Macaulay Viron Therapeutics Inc. 15 Nov 2012

2 Viron Therapeutics Inc. Virtual Biotech Company (6) Phase 2a (48 pt) clinical trial in acute coronary syndrome (ACS) completed Reduction in cardiac biomarkers and clinical events Improved product pharmacokinetics Completed new manufacturing process Completed nonclinical efficacy, safety and tox Completed HC Pre-CTA meeting Raising Money for Follow-on Clinical Trial Repeat and extend findings from first study with new modified product Approach Outsourcing from the view point of a virtual biotech (VB) company 2

3 VB Outsourcing Landscape VB Considerations: Capacity Expertise Quality / Regulatory Clinical Trials Manufacturing VB VB Outsources to leverage expertise (best practices) and capacity in all areas. Non Clinical Pharm/Tox Analytical VB is very price sensitive, but execution risk is even more important. Poor execution can kill a company. 3

4 VB (Sponsor) Clinical Trial Responsibilities (ICH-E6) Clinical trial design (protocol and protocol amendments) Trial management (allocation of trial responsibilities) Investigator selection (qualification) Regulatory submissions Confirmation of institutional IRB/IEC review and approval Investigational product safety and efficacy information summarized in the Investigator s Brochure Investigational product manufacturing, packaging, labeling and coding Investigational product supply, instructions for use, and documentation of disposition Ensuring access to source data for trial-related monitoring, audits, IRB/IEC review and regulatory inspection Adverse Drug Reaction Reporting Clinical site monitoring (qualification of the monitors) 4

5 VB (Sponsor) Obligations The Sponsor is Responsible for: Implementing and maintaining quality assurance and quality control systems (ICH-E6 sec5.1). Approving or rejecting drug products manufactured, processed, packed, or held under contract by another company (21CFR211). The Sponsor May: Delegate, in writing, specific responsibilities to other companies (CROs, CMOs, etc), but overall responsibility always resides with the Sponsor. Ref: Laurie Halloran (2012) A Primer on Vendor Oversight for Clinical Project Managers Draft Guidance: Oversight of Clinical Investigations UCM pdf FDA Compliance Program Guidance Manual, Ch48 Bioresearch Monitoring UCM pdf 5

6 Quality Management System Quality Manual Quality standards, objectives and policies; controlled documentation, change control system, CAPA system, documented training program, quality assurance oversight, vendor management, and executive management oversight GMP Manual Policies, procedures, and documentation to ensure oversight of manufacturing GLP Manual Policies, procedures, and documentation to ensure oversight of nonclinical studies GCP Manual Policies, procedures, and documentation to ensure oversight of clinical trials Vendor Oversight is essential for Virtual Biotech operations and success 6

7 Vendor Outsourcing Flow Chart Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Vendor Management 7

8 Vendor Outsourcing Flow Chart Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Goal: Understand the entire project, control budgets, and minimize risk Define project scope Understand your role (what responsibilities are you outsourcing) Understand the details Minimize risk Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Vendor Management 8

9 Define the Clinical Project Regulatory Medical Mgmt IRBs Drug Supply VB CRO (Trial Mgmt) Clinical Sites DSMB Data Mgmt Patients Stats Central Labs 9

10 Understand the Details Study design finalized Schedule of activities finalized Finances activated Protocol finalized ICF /PIS finalized CRFs finalized SOPs / WP/ TMF Ethics and regulatory approvals obtained Risk Assessment carried out Sites selected Contracts / Subcontracts signed Committees established Build database and develop DM plan Finalize intervention / logistics Study Kickoff meeting and training Distribution of study drug to sites/train on intervention Enroll subjects recruitment / randomization Answer protocol/crf questions Ref: Communication with all parties Data query process Monitor recruitment & Follow up Monitor Sites Monitor SAEs Committees meet Clean/Close database Database Lock Perform primary/ secondary analysis Submit abstracts Submit manuscript Post-hoc analysis Initiation Planning Execution Monitoring & Analysis/ Reporting Publication 10

11 Minimize Protocol Risk Clinical Protocol Meet with PIs and KOL in the therapeutic area Go over details of the trial design and protocol Ensure study can be run (is it within standard of care) Ensure patient population exists and get approximate numbers Inclusion/exclusion criteria are not too restrictive Enquire about their experience with CROs in the therapeutic area Identify candidate CROs 11

12 Initial RFP Submission Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Vendor Management Goal: compare multiple CROs with same project synopsis (RFP) to develop an initial budget Include as much detail as possible: Protocol synopsis; #patients; treatment plan; assessments details and timing; #clinical sites and general location (Can, USA, EU); SAE frequency; DSMB; etc. Example: 72 Patients Receiving a Coronary Stent 12 sites in Canada Treatment on day of stent placement Collect safety data for 30 days Bid Grid Overview 12

13 Bid Grid Overview Categories CRO-1 CRO-2 CRO-3 CRO-4 Study Start-Up/Planning $48,000 $124,690 $186,032 $23,568 Clinical Trial Management $330,240 $137,965 $346,260 $259,466 Clinical Monitoring $195,240 $289,980 $222,721 $390,170 Data Management $231,380 $95,625 $122,302 $232,899 Biostatistics (Statistics + DSMB) $147,015 $123,126 $73,647 Incl. Medical Writing (Clinical Study Report) $45,000 $39,640 $42,892 $17,990 Regulatory $21,600 $30,240 $30,401 $2,030 Medical Management $128,000 $57,500 $151,595 $31,538 Quote Subtotals $1,146,475 $898,766 $1,175,850 $957,659. Pass Through Costs $879,880 $570,135 $130,330 $83,850 13

14 Revised RFP Submission Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Goal: Get as close to an apples-to-apples comparison as possible Incorporate allchanges in scope and any additional details into the final RFP for candidate CROs Final Selection Contracts (MSA, SOW, QA) Vendor Management 14

15 Vendor Qualification Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Goal: Vendor Qualification Quality/Regulatory Audit GCP Compliance (483s) QMS in place and followed Training Records Key SOPs Financial Health Reference Checks Human Resources Capacity, and capability Turnover Other Factors (project specific) Vendor Management 15

16 2008 Survey Key Factors in CRO Selection 1. Team Chemistry PM teams share the same values (work ethics, communication, shared goals) 2. CRO Experience Therapeutic area and specific clinical indication 3. Project Execution Plan A plan that details specifics for executing the project 4. Problem Solving Process How are issues identified, communicated and resolved Who makes the decisions 5. Other Factors Geographic coverage Therapeutic Focus Staff Turnover (PM, CRA, etc) Cost Ref: Glass and Beaudry, Applied Clinical Trials 1Sep

17 CRO Score Cards Criteria Rating Weight Criteria Rating Weight CRO 1. Evaluation Team Criteria Chemistry CRO Evaluation Criteria I. Financial Stability Y/N Y/N V. IT Score/Weight a. Do the two teams work well together Score/Weight (values, work ethic, responsiveness) Score 1-5 Weight=16 D&B Rating CFR 21 Part 11 Compliance b. A good relationship can overcome issues, rather than exacerbate them Revenue Trend (last three years) Connectivity to internal systems Revenue 2. Per CRO Employee Experience VI. Risk Benefit II. Service Capability Score/Weight Y/N Y/N Score/Weight a. Clinical indication Score therapeutic 1-5 Weight=26 area, % of and Business geography with Sponsor Company depending on specific Capacity M&A Status needs. Geographic Reach Litigation Therapeutic Expertise VII. Customer Service Level 3. Quality of the Project Execution Plan III. Human Resources Score/Weight Score 1-5 Weight=26 Score/Weight a. How will the project Score be 1-5accomplished; Weight=21 Ease the of number Service one risk is execution risk Voluntary Turnover Rate in % (last 3 years) Sponsor Studies (Year to Year Revenue) Qualified 4. People Issue Identification and Resolution Total Score Max of Years of Experience/Therapeutic Experience IV. Quality a. Assurance What processes are used, who is the Score decision maker on both sides (how far Score/Weight up the food chain) Score 1-5 Weight=16 1 = Fails to meet rqmts Regulatory Audit 2 = Partially meets rqmts 5. Date of Last Other Audit Factors 3 = Meets rqmts 483 Observations Cited? 4 = Exceeds rqmts Certifications (eg ISO 9000, other?) 5 = Greatly exceeds rqmts a. Price; geography; staff turnover (CRA, PM); others Ref: 17

18 Vendor Contracts Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Negotiate Contracts with CROs Master Service Agreement: Scope of work, transfer of responsibilities, associated budget and payment terms Quality Agreement Oversight Agreement? Vendor Management 18

19 Vendor Management Define Project Scope Initial RFP (Budget) Project Refinement (Scope & Budget Changes) Vendor Qualification Final Selection Contracts (MSA, SOW, QA) Goal: To provide oversight of Vendor activities to ensure transferred responsibilities are being carried out and the rights, welfare, and safety of study subjects are adequately protected. Vendor Management is broadly defined in SOPs as part of the Sponsor s QMS Vendor Management 19

20 Vendor Oversight Proactive Approach Written Transfer of Sponsor s Obligations Including agreement on SOP use (Sponsor or Vendor s) Study Specific Procedures definition and training Quality Agreement Defines responsibilities and deliverables for quality mgmt of a Clinical Trial Defines communication process and timelines Vendor Oversight Plan Evaluating vendors service against their contract Written plans to monitor activity and performance Visit Clinical Sites 20

21 CRO Outsourcing Summary Define project scope in detail Understand roles and responsibilities of sponsor and vendors Minimize Risk Protocol risk Changes in scope & budget Formal written Vendor Qualification Process Contracts MSA, SOW (budget), Qual. Agreement, others? Formal Written Vendor Oversight Plan 21

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