Clinical Operations Consulting
SDS Clinical provides clinical trial consulting that cover a range of services in the Clinical Operations, Development, and Clinical trial execution space.
These include but are not limited to:
- Governance and oversight of the development process
- Business infrastructure and business process improvement
- Identification, design and creation of key Standard Operating Procedures (SOP’s)
- Vendor selection, management and oversight
- Trial rescue and replacement monitoring services
Governance and oversight of the development process
The governance and oversight of clinical programs and the development process can be a complex and multifaceted task in our highly regulated environment.
The effective oversight of this process is crucial to success and this requires a sound understanding and experience in implementing
- Cross functional integration
- Team building and motivation
- Effective resourcing strategies and management
- Enhancing team and project communications
- Clinical Operations group management
- Independent vendor oversight
- Quality control measures, compliance assessments Independent monitoring audits
Business Infrastructure and Business Process improvement
The creation of an effective clinical operations structure / team, and the management of the growth of that team as development portfolio’s and clinical trials expand are both challenging enterprises in and of themselves.
The challenge is not only in having the right team members but also in having the right relationships defined, the right support in terms of systems, communications, processes and procedure, strategies, organization, and training. All need to be well-defined and in place to facilitate the efficient execution of the trials to meet corporate goals at each stage of a company’s growth.
SDS Clinical can apply its proven success in each of these enterprises, providing assessment, guidance and recommendations on
- Team structures
- Central file structures, and requirements, both paper and electronic
- Systems support including Clinical Trial Management Systems (CTMS) if appropriate
Identification, design and creation of key Standard Operating Procedures (SOP’s)
SDS Clinical can provide support to optimize the clinical operations and trial execution business processes. As well as assessing the current state of information and task flows in the trial process, SDS Clinical can provide a review and audit of existing Standard Operating Procedures (SOP’s), and create, write and/or expand the SOP’s as needed or required.
Vendor Selection, Management and Oversight
Where clinical trial services are fully outsourced, high quality vendor management and oversight is crucial to successful trial execution and in meeting corporate goals. Getting this right involves accurately defining the scope of the projects, specifying key performance metrics and indicators, negotiating equitable rates for the work, (and accurate tracking of both to assure performance), along with invoicing and payment to assure commitments and obligations are met in a timely manner.
SDS has the proven experience to give insightful assistance from the start of the process, from the creation of Requests for Proposal (RFP’s), subsequent bid defense meetings and vendor selection, through the initiation, conduct and closeout phases to a successful project completion.
If you need assistance in managing vendors, developing the strategy for executing your clinical trials and in implementing the right structure and groups to conduct that development work please call us.
Trial rescue, performance intervention, and/or replacement monitoring services
If your trial is not meeting its timelines, if recruitment is not progressing as fast as possible, or PI’s and research sites are not engaged in the trial conduct, there is a need to intervene and identify the limiting factors. SDS Clinical can provide assistance in identifying these factors that are negatively affecting the trial execution, team, and / or the vendor performance, assess the extent that the trail is at risk, and propose creative strategies to help mitigate these performance issues.
SDS Clinical has proven experience and results in replacing regional monitoring services and turning around enrollment and site engagement.