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:
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:
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.
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.
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.
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.
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.
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.
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.
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.
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