SCDM Vendor Selection and Management 2023

Vendor Selection and Management

Vendors provide services that are critical to the successful outcome of a clinical study, yet sponsors retain the ultimate responsibility for activities that are outsourced.

sponsor should take measures to ensure the vendor is delivering products or services of acceptable and repeatable quality.

Vendor Selection and Management Minimum Standards

Document the sponsor's process and support functions that are needed to evaluate the use of vendor services.​

Evaluate and qualify (e.g., capacity, qualifications, experience, regulatory compliance, company stability, etc.) vendors prior to contracting for their services or products.​

Vendor Selection and Management Minimum Standards

Obtain a confidentiality agreement with the vendor prior to exchange of proprietary information.​

Create a contacts list that is centrally accessible to study team members.​

Vendor Selection and Management Minimum Standards

Determine and document whether the sponsor's or vendor's standard operating procedures (SOPs) (or a combination of procedures) are to be followed.​

Clearly define expectations, deliverables and responsibilities. Both the sponsor and the vendor must participate in establishing definitions of their roles.​

Vendor Selection and Management Minimum Standards

Conduct ongoing management of vendor activities.

Communicate and assess the vendor's performance throughout the study.

Vendor Selection and Management Best Practices

Establish a cross-functional vendor auditing program based on established services, which should include plans to re-audit the vendor within a stated amount of time, if applicable.​

Oversee vendors by utilizing subject matter experts within a centralized organizational team to provide input into the processes of vendor evaluation, vendor audits, and issue resolution and escalation.​

Vendor Selection and Management Best Practices

evaluate from a CDM perspective the risk of utilizing or not utilizing vendor services related to the conduct and outcome of the study.​

Maintain an internally approved vendor list with regular evaluations (e.g., preferred vendor list or prequalified vendor list).​

Vendor Selection and Management Best Practices

Define and document a detailed statement of work and project plans that detail who is responsible for each task; who is responsible for reviewing and approving various documents; details of project reporting; or a checklist of tools, processes, and services to be performed by the sponsor and vendor at each phase of the study.

Define and document detailed sponsor/vendor communication plans that clearly address the expected communication tools and frequency, as well as establish who is responsible for communications and how to escalate issues when deemed necessary.​

Vendor Selection and Management Best Practices

Identify other possible vendors or options as part of a contingency plan in case the vendor relationship is deemed unsatisfactory at any point during the course of the study.​

Establish a collaborative relationship based on partnership, trust and co-ownership of the project.​

Vendor Selection and Management Best Practices

If the vendor is providing services that involve computerized systems, ensure system support documentation is in place, such as a service level agreement (SLA), that describes in detail how much time it will take the vendor to respond to support inquiries, how long it will take to get a database back online

Types of Vendor Services

Data management CRO

CRF/document printer​

Translation services​

External data providers: vendor evaluation should ensure vendors provide data that consistently meet quality standards defined for the study. ​

Software and hardware providers​

Server or network providers​

Coding services​​

Transactional Model

Sponsor contracts vendors on a per study or per trial basis.
A detailed cost and scope of work, including changes in costs, are required for this type of outsourcing

Strategic Partnership

An agreement between two or more organizations to share complementary resources to increase efficiencies and lower costs

Functional Service Provider (FSP)

Outsourcing select activities

Application Service Provider (ASP)

an agent or vendor who assembles the software needed by enterprises and packages them with outsourced development, operations, maintenance, and other services

First Steps in Vendor Qualification (Before qualifying vendors)

Sponsor must decide what services require assistance from a vendor and must define desired attributes that will be most important in the selection of vendors (i.e. company size, location, and portfolio).

What services will be provided​

Whether the data in the clinical study could be directly or indirectly affected by these services

3 Attributes a Prospective Vendor should have

Sufficient staff,
adequate standards requirements,
staff is adequately qualified and trained

Request for Information (RFI) includes:

Company historical info,
products and services,
experience and areas of expertise,
product demonstration, computerized systems,
results or previous regulatory inspections.

Subject Matter Expert (SME)

Person who is well versed in the content of a human resource development program.

Result of Vendor Deficiencies

Identified deficiencies don't necessarily result in vendors being eliminated from selection. Deficiencies can be addressed by corrective actions or setting proper controls/assurances over the vendor.

Contract and statement of the scope of work

2 documents that are required before a business relationship is official

Development of Contract and Scope of Work (SOW) - considerations

Task Ownership Matrix ​(RACI table)
- clearly identifies who is responsible, accountable, consulted, informed for the task/document.

Bid Grid​
- captures the sponsor's predefined study-specific cost drivers. ​- allows the outsourced partner to assign prices to specific tasks associated with cost drivers.

Development of Contract and Scope of Work (SOW) - Categories

CRF design ​
Database development (including edit check specifications) ​
Data management plan development ​
Data cleaning ​
Management of local lab reference ranges ​
Data encoding (including panels to be encoded, dictionaries and versioning) ​
Management of external data ​
SAE reconciliation ​
Quality control audit(s)​
Data transfers ​
Database finalization/lock

SOW CDM Cost Drivers

Number of unique CRFs (paper or electronic) ​
Number of total CRF pages (paper or electronic) ​
Number of subjects to be enrolled ​
Number of cleanup listings ​
Number of external data sources (e.g., central labs, electronic diaries, etc.) ​
Number of local labs ​
Number of queries expected ​
Number of terms to be encoded ​
Number of SAEs to be reconciled ​
Number of data review rounds ​
Number/types of data transfers ​
Number of unique status reports ​
Frequency of status reports ​
Frequency of teleconferences ​
Number of interim database locks

SOW agreement between sponsor and vendor

Communications (project status updates, escalation path, etc.) ​
Quality (documents and data) ​
Timelines and turnaround times ​
Final deliverables

Vendor Oversight - Resource Management​

Both Sponsor and Vendor must ensure that they shall maintain sufficient resources for the duration of the contract.Vendor must ensure that they shall maintain sufficient resources for the duration of the contract.

Vendor Oversight - Governance Documents​

- Training and on boarding plans ​
- Transition plans to cover staffing changes ​
- Key milestones on study timeline ​
- Performance metrics definitions ​
- Communication plan (to include roles and responsibilities) ​
-Escalation plan ​

Vendor Oversight - Study Startup

The sponsor must ensure that the vendor's team is thoroughly trained on the sponsor's systems and SOPs where applicable. ​

Project-specific training​
- Retraining study-specific processes and parameters should be carefully considered ​

Timeline planning and review​
- Project milestone tracking tools/metrics

Vendor Oversight - Study Conduct

Timeline management​
Scope management​
Key performance indicators​
Data quality oversight​
Compliance​
Relationship Governance

Vendor Oversight - Study Closeout

Conduct database finalization activities ​
Conduct lessons learned meeting with all stakeholders to identify successes and challenges to be mindful of for future projects ​
Finalize and archive all relevant communications and data management documents according to applicable SOPs. ​
Recognize the team for their contribution.

Vendor Milestones

These should be based on the defined deliverables and need to be monitored through regular communication and status updates provided to the sponsor.

Recommended SOPs

Vendor Qualification and Selection
Specifications for Outsourced Deliverables
Ongoing Vendor Management
Vendor Auditing Specific to Types of Vendors
Vendor Relationship Termination