Vendor Engagement & Oversight (VEO)

Chaucer / Life Sciences / Data Enabled Operations / Vendor Engagement & Oversight (VEO)

Chaucer’s Vendor Engagement and Oversight (VEO) approach has been developed and field tested for Sponsor and Vendor organisations.

Life Sciences organisations are increasingly using third party vendors to manage and undertake clinical trials. The clinical outsourcing market is predicted to grow to $59 billion by 2020 which will mean enormous complexity and a high level of risk. The new ICH E6 (R2) guidelines also strengthen the need for sponsors to oversee the delegated vendor responsibilities.

Outsourcing models vary between organisations but we have developed a framework and toolset to support both sponsors, Contract Resource Organisations (CROs) and vendors of all kinds.

Along with some of the world’s largest Life Sciences organisations, we use our VEO approach to analyse and optimise the relationship, risk, compliance, quality and delivery processes.

This has enabled our clients to achieve significant improvements in:

  • Monitoring of vendor performance across the engagement lifecycle
  • Alignment of sponsor, vendor standards and processes to ensure Good Clinical Practice compliance
  • Realisation of the benefits of vendor engagement through the tracking of performance and costs

Vendor Health Check

Our VEO approach starts with Vendor Health Check which evaluates the ‘fitness’ of your organisation, your vendors and the relationship between them. It will identify:

  • The current gaps or issues which require attention during vendor engagement
  • Elements where you are out of compliance in relation to the most recent regulations, including ICH E6 (R2)
  • The key drivers to delivering Good Clinical Practice – providing opportunity to reduce Costs, increase Quality and provide a healthy way forward for the sponsor/vendor relationship

Email Chaucer : VEO@Chaucer.com to find out more about our VEO Health Check and VEO services.

Our ultimate aim is to give you the tools and processes to improve your capabilities but our consultants are always on hand for your changing business needs.

The Benefits to You:

  • More flexible strategic sourcing
  • Continuous improvement
  • Stronger, value-based relationships
  • High performing, metrics based, compliant culture​

Highlights from our Recent Projects

FLEXIBLE VENDOR QUALITY OVERSIGHT FRAMEWORK

Optimization of benefits of using vendors for clinical trials from the perspective of cost, time and quality. Independent review of current systems and processes related to Vendor Management. Increased colleague awareness of vendor management responsibilities and techniques to improve oversight leading to reduced risk and favorable outcomes.

UNIVERSAL QUALITY STANDARDS

Clinical Trial process harmonization & simplification across over 10K global employees and vendors. Revision of SOP infrastructure and sponsor requirements. Reduction from 50+ segmented processes to 26 streamlined and connected SOPs and supporting documentation.

CLINICAL TRIAL OPERATIONS PROJECT MANAGEMENT PROCESS CREATION

Formalization, development and implementation of a Study Execution process with a focus on collaboration between sponsor and vendor roles and responsibilities. Rollout and vendor implementation on process requirements.

CRO ALLIANCE PARTNER ON-BOARDING

Development of repeatable on-boarding process for full service CRO partners to sponsor process, systems and requirements. Established recommended PMO structure, delivered clinical trial process workshop sessions, early adopter’s program and on-boarding transition to business as usual.

VENDOR REMEDIATION ACCOUNTABILITY

Implementation of a remediation tracking tools to report issues and mitigations at the study and process levels. Accountability driven to study team project managers supported by CRO providers.

DATA STEWARD PROJECT / DATA QUALITY MANAGEMENT PLAN

Managed process of receiving and mastering data from CRO vendors during post implementation period of new data warehousing technology. Data oversight and issue management across data providers was required to ensure the high standard of quality. Developed strategy and implemented plan to improve data quality received from vendors.

CLINICAL TRIAL PLATFORM EVOLUTION

Lead program to implement new CTMS, CDMS and QMS tools across global pharmaceutical company and its CRO partners and vendors. Decommissioning existing systems, data transfer, knowledge gaps, training, implementation planning and execution. Requirements scoped to include enhancements and automations related to clinical trial execution.

VENDOR 90 DAY PLAN REMEDIATION

Evaluation of vendor adaption to sponsor requirements post on-boarding leading to 90 day remediation plan to strengthen operational infrastructure and knowledge. Managed and closed 90 day plan and developed follow-on performance plan to address start up and conduct performance issues.

Chaucer’s understanding of the processes combined with their ability to integrate with our team and facilitate and manage the preparation activities was key to a successful outcome.Global Tier 2 Life Sciences company

If you think we can help you to implement your project or programme strategy, please call us on:
+44 (0) 203 141 8400 in UK/Europe, or ​​​+1 713 821 1783 in the USA.

Alternatively, please send us some brief information and we can discuss things in more detail.