Clinical Operations

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
  • Hands-on management of sites to assure clinical trials are monitored according to protocol, company’s SOPs, European and US regulations and international Good Clinical Practice (GCP) rules
  • 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)