Support for Sponsor Companies
Although randomisation of subjects and effective management of drug supplies is a critical part in the drug development process, most small to medium sponsor companies (and some big pharma) have little or no internal expertise in this area. Project managers and Clinical Supplies managers often find it hard to make sense of the maze of technical documentation presented to them by their service providers.
Sponsor companies find themselves unable to leverage optimised internal processes since their study teams work in isolation from one another and each manages their IRT systems and service providers the best they can. Lessons fail to be learned, best practices are not established and relationships with partner companies falter.
We, at Clinical Technology Consultants, offer help through a range of consultancy services including those in the following areas:
- Support of study teams to guide them to a clearer understanding of their individual study needs and best approaches to data capture for their specific study
- Review of User Requirement documents and interpretation into terms clinical study teams will more readily understand
- Development of UAT plans
- Authoring of UAT scripts
- On-site support during UAT
- Development of UAT processes including appropriate documentation and filing
- Development of SOPs
- Development of standard IRT templates and requirements
- Innovative solution development for accountability and return of study drug
- Development of unique and innovative solutions in areas such as
- Clinical supply management for controlled substances across a number of clinical studies/ development programmes
- Identification of duplicate subjects across clinical studies/ development programmes
- Mobile data capture solutions for use at a site or subject level
- Expert, neutral, guidance in the selection of Preferred Service Providers and the on-boarding of new partner companies.
- Development and agreement of standard data transfer and integration documentation for
- 3rd Party data integrations
- Statistical partner systems
- Vendor management
- Establishment and coordination of regular Governance and Portfolio Review Meetings