GCDMP: 4. Vendor Selection and Management (2021)

Vendor

External entity providing critical services for clinical studies.

Sponsor

Entity with ultimate responsibility for outsourced study activities.

Regulatory Standards

Guidelines like ICH E6(R2) ensuring quality and integrity in trial data.

Outsourcing

Delegating study activities to external entities like vendors.

Contract Research Organization (CRO)

Entity handling trial-related duties on behalf of sponsors.

Quality Management Systems

Standards ensuring quality of goods and services.

ISO

International Organization for Standardization.

Project Management Institute

Organization maintaining PMBOK and certifying project managers.

21 CFR Part 312

Regulations specifying sponsor and investigator responsibilities.

Risk Identification

Process of recognizing and evaluating potential risks.

Vendor Scope of Work (SOW)

Document outlining vendor responsibilities and deliverables.

Relationship Management

Strategies for maintaining effective vendor-sponsor interactions.

21CFR312.52

Regulation detailing transfer of sponsor obligations to CROs.

Quality Assurance and Control

Methods ensuring quality and integrity throughout trial stages.

Best Practices

Recommended approaches supported by evidence or consensus.

GCDMP Levels of Evidence

Framework categorizing strength of evidence in GCDMP chapters.

Vendor-Auditing Program

Program for assessing vendor performance and ensuring compliance.

Human Subject Protection

Ensuring ethical treatment and safety of study participants.

Reliability of Trial Results

Ensuring accuracy and consistency of trial outcomes.

Confidentiality Agreement

Agreement securing proprietary information exchange.

Sponsor's Process Documentation

Record of necessary functions to assess vendor services.

Vendor Qualification

Assessment based on capacity, capability, experience, compliance.

Contacts List

Centralized list accessible to study team members.

Standard Operating Procedures (SOPs)

Guidelines to be followed from sponsor, vendor, or both.

Expectations Definition

Clear definition of responsibilities and deliverables.

Ongoing Vendor Management

Continuous assessment and communication of vendor performance.

Data Transfer Agreement

Agreement for third-party vendor data transfers.

CDM Risk Evaluation

Assessment of risks related to vendor services.

Vendor List Maintenance

Regular evaluation and approval of vendors.

Vendor Evaluation Processes

Informed by subject matter experts.

Statement of Work Definition

Detailed project plan delineating tasks, roles, timing, and reporting.

Communication Plans

Detailed sponsor/vendor communication strategies.

Contingency Planning

Identifying alternative vendors in high-risk scenarios.

Collaborative Relationship

Partnership based on trust and project co-ownership.

Vendor Meetings

Regular one-on-one sessions for feedback and issue resolution.

System Support Documentation

Ensuring support for computerized systems.

Sourcing Strategy

Early engagement for vendor identification.

Service Level Agreements (SLAs)

Defined agreements for frequent vendor collaborations.

Independent Consultants

Individuals hired for specific projects or programs.

Transactional Model

Traditional per-project outsourcing model.

Strategic Partnerships

Collaborations for complementary resources.

Third-Party Vendors

Independent subcontractors for additional services.

Corporate Culture Evaluation

Assessment to avoid conflicts among partners.

Strategic Partnerships Benefits

Cost reduction, efficiency improvement, access to expertise.

Strategic Partnership

Requires time and resources from both parties for mutual benefit

Request for Information (RFI)

Gathers vendor information for study-level sourcing strategy

Functional Service Provider (FSP) Models

Outsources select activities, maintains project ownership in-house

Application Service Provider (ASP) Models

Vendor leases software application to clients

Bid Grid

Captures study-specific cost drivers, allows task pricing

Cross-Functional Team Discussion

Review of vendor information by diverse teams for study needs

Request for Proposal (RFP)

Document for potential suppliers to submit business proposals

Bid Defense

Vendor presents proposal contents in face-to-face or teleconference meeting

Quality Management System (QMS)

Vendor's system for maintaining quality standards

Service Level Agreement (SLA)

Agreement outlining service expectations and quality

Data Management Plan

Document outlining data handling processes for a study

Regulatory Inspections

Audits to ensure compliance with regulations

CRF/eCRF Design

Creation of case report form/electronic case report form

Database Finalization/Lock

Securing database after data collection and cleaning

Data Cleaning

Process of identifying and correcting errors in data

SAE Reconciliation

Matching and resolving serious adverse event data

Quality Control Audit(s)

Review process to ensure data accuracy and compliance

Data Transfers

Movement of data between systems or parties

Disaster/Contingency Plan

Strategy to protect business operations in emergencies

Data Review Rounds

Number of rounds to review and verify data accuracy

Patient Profiles Reviews

Evaluation of patient data profiles if utilized in the study

Interim Database Locks

Temporary securing of database at specific study milestones

Roles and Responsibilities (R&R) Matrix

Bid grid indicating task ownership and responsibility assignment

Vendor Audit Program

Program to assess vendor performance and compliance

Information System Validation

Process to ensure software meets regulatory requirements

RFP/Bid Grid

Document circulated for function-specific review

Functional Assessment

Review process by senior personnel from each function

On-site Assessment

Visit to vendor's location for evaluation

Statement of Work (SOW)

Legal document defining services, deliverables, and timeline

QMS Audits

Quality Management System audits indicated in the RFI

QC/QA Processes

Evaluation of vendor's quality control/quality assurance processes

Personnel Qualification

Review of team members' qualifications

Development of Contract

Preparation of official agreement with vendors

Scope of Work (SOW)

Details high-level services, deliverables, and costs

Security of Physical Locations

Ensures controlled access, backup procedures, etc.

Master Services Agreement (MSA)

Initial agreement outlining future contracts

Acceptance Criteria

Criteria for satisfactory completion of services

Service Level Agreements

Agreed time-based expectations for services

Change-In-Scope (CIS)

Negotiated change due to alterations in SOW

Task Ownership Matrix

Identifies responsibilities for tasks and documents

Risk-Based Vendor Oversight Program

Program to manage and oversee vendor activities based on risk