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KasaConsult offers a full range of Clinical Operations services to support sponsors in research and development: - Definition and implementation of clinical strategies by working hand in hand with the sponsor.
- Preparation of clinical project timelines and provision of corresponding resources plans.
- Identification of key opinion leaders and investigators, qualification and selection of investigational sites.
- Outline of study specific patient recruitment strategies and programs.
- Organization of strategic committees and meetings with investigators and Sponsor.
- Negotiation in conjunction with sponsor of contracts/fees with investigators and other parties at the investigational site.
- Preparation, assemblage and maintenance of study documentation, Case Report Forms, binders, investigational products, clinical supplies, etc
- Provision of comprehensive study updates and monitoring reports
- Mediation between sponsor and outside vendors in Europe
- Setting up reporting systems consistent with sponsor proprietary requirements
- Performing all kinds of monitoring visits
Reporting and tracking of (serious) adverse events (AE/SAE) - Creation and management of tracking tools for enrolment, essential documents, monitoring, patient and/or CRF tracking, drug accountability, queries, addenda and adverse events, including SAE
- Executing rescue studies (Swat-and-Sweep approach)
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