Services
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- Category: Uncategorised
- Published: Thursday, 22 October 2015 15:54
- Written by Super User
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Smerud excels in all services required to develop a product; from strategy planning, to processing marketing authorisation.
We are highly competitive in quality, time and cost - particularly as we can provide clients with reliable and documented feasibility information before costly drug developmentAt SMERUD, we are capable of offering anything from management of an entire clinical drug development programme, to provision of a stand-alone functional service in one study or project, only. Having played a role in developing drugs for 28 years, we have acquired full-service expertise in the planning, conducting, analysing and reporting of clinical trials, and we fully understand the critical importance of quality, time and cost in such projects. SMERUD is proud to offer our clients a comprehensive portfolio of functional clinical trial services.
STUDY PHASES
We deliver our service in all clinical study phases,
• Phase 0: microdosing studies
• Phase I/Ib: First-in-Man and First-in-Patients studies
• Phase IIa: clinical Proof-of-Concept studies
• Phase IIb: dose-response studies
• Phase III: therapeutic confirmatory studies
• Clinical validation/utility studies
FUNCTIONAL SERVICES OFFERED
• Clinical Project Management
• Feasibility analysis
• Regulatory affairs
• Site management and monitoring
• Data management
• Biostatistics
• Pharmacovigilance & medical monitoring
• Medical writing
• Clinical trial supplies
• QA & auditing
• Training
• Legal representation
• Consulting
Individual functional services are presented in more details below, whereas for integrated, full-service assignments we develop a tailor-made plan for the specific project as per our SMERUD SYSTEM™. The SMERUD SYSTEM™ is a proprietary project management system scaled to fit our needs, typically managing phase II trials, but should larger trials be requested, we can easily scale up our management tools.
Key to the success of a full-service project is the Project Manager. The project manager will break down the project goals and scope into deliverable components, compile a project plan and associated documentation and oversee the work of the project team to ensure the timely delivery of project-specific milestones. The project manager will be the main contact for our client and will provide routine project updates on study progress.
The project team will be assembled following award of the contract and determination of the country in which the trial will be conducted. In general, in order to keep costs to a minimum it is recommended that a flat team structure is implemented according to the following model.
