SMERUD is providing senior clinical development expertise to the market. The majority of our clients in the consulting market are small-to-medium sized enterprises, typically with very strong drug discovery, laboratory and/or pre-clinical modelling experience, but with relatively scarce experience from clinical development. In most cases, the client would present to SMERUD their current overall idea about their target indication and target market. SMERUD’s consulting unit would then typically be assigned to establish ‘the optimal clinical development strategy’, materialized through a detailed, integrated Clinical Development Plan (CDP). The CDP would include the desired Target Product Profile (TPP) and a detailed description of all activities to be completed in order to attain the attributes defined in the TPP, and with associated crude budgets. The timing of all activities including deferral of non-critical activities until completion of clinical proof-of-concept would be outlined.
It is typically our responsibility to manage the full drug development programme, or an individual trial, according to plan. However, since such undertakings are very seldom foreseeable, ‘things’ will happen in a clinical setting, our (and thus the project’s) success will very much depend on us being able to proactively foresee and prevent critically negative events to occur. Our primary expertise is to guide smaller biotech clients to keep their early-phase clinical trial on the right track.
With our 30 years’ experience in the market as a CRO, in which we have been involved in more than 2000 different clinical trials, we provide deep knowledge from a wide variety of therapeutic areas and clinical development activities. We have acquired full-service expertise in the planning, preparation, conducting, analysing and reporting of clinical trials, and we fully understand the critical importance of quality, time and cost in such projects.
At SMERUD, we are therefore 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. SMERUD is proud to offer our clients a comprehensive portfolio of functional clinical trial services. In addition to the HQ-based specialists, all our local offices are manned with local experts on how clinical trials are best set up and managed in that particular country.
FUNCTIONAL SERVICES OFFERED
- Clinical Project Management
- Feasibility analysis
- Regulatory affairs
- Site management and monitoring
- Data management
- Pharmacovigilance & medical monitoring
- Medical writing
- Clinical trial supplies
- QA & auditing
- Legal representation
STUDY PHASES COVERED
- 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
The SMERUD SYSTEM™
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.
Activities within the SMERUD SYSTEM™:
- overall coordination of functional service groups
- key study document development
- selection of central or local laboratories incl. agreements
- clinical trial applications to competent authorities and ethics committees
- clinical trial supplies inventory, including study medication,
- subject recruitment status
- oversight of site management and monitoring incl. review and sign-off of monitoring visit reports
- project finances, incl. coordination and processing of investigator fee payments
- ensuring acceptable quality standards throughout the project
- tracking and management of key milestones and deliverables
- meetings (preparation, conduct and minutes)
- Trial Master File set-up and maintenance
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.
Our mission is to keep your project on the right track