Clinical Trials of New Medicines in Practice: Contracts, Budgets, and Negotiatio












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            CONTACTS */ .cuni-person-wrapper { margin: 0; padding: 0; } .cuni-contact-group { margin: 
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            a { color: #d32f3f; font-size: inherit; text-decoration: none; font-weight: 400; } .cuni-c
            a:hover { text-decoration: underline; } @media (max-width: 600px) { .cuni-btn-secondary { 
            0 0; } } </style> <div class="cuni-clean-wrapper"> <!-- SUMMARY --> <div class="cuni-annot

            <strong class="title-label">Summary</strong> This lecture offers academic staff a practica
            on the contractual and financial aspects of clinical trials and explains how to negotiate 
            with CROs and Sponsors. It shows how well-structured contracts and budgets protect the ins

            Principal Investigator, and the study team, while potentially bringing more than 25% in ad
            to the research site. </div> <!-- CTA --> <div class="cuni-cta"> <div class="cuni-cta-text
            in the program? Please submit your request using the form. We will then contact you to dis

            and arrange a suitable date. </div> <a href="https://forms.cloud.microsoft/Pages/DesignPag
            origin=NeoPortalPage&subpage=design&id=2naS4DT5hkC_CIgWogQUopHVOtuey35BmpqUBmwwGdNUNEpDMUd
            target="_blank" rel="noopener" class="cuni-btn-link"> Request Form </a> <a

            href="mailto:ivo.svejkovsky@ruk.cuni.cz?subject=Request – Clinical Trials of New Medicines
            Practice&body=Dear Sir or Madam,%0A%0AI have a question regarding the Clinical Trials of N
            in Practice program.%0A%0A" class="cuni-btn-secondary"> Contact the Lecturer </a> </div> <

            INFORMATION --> <h2 class="cuni-heading">Basic Information</h2> <ul class="cuni-params-inl
            <strong>Program type:</strong> Lecture </li> <li> <strong>Target audience:</strong> Academ
            staff, physicians, Principal Investigators (PIs), and other professionals involved in clin

            li> <li> <strong>Duration:</strong> 2–3 teaching hours, as needed </li> <li> <strong>Capac
            Unlimited </li> <li> <strong>Language:</strong> Czech </li> <li> <strong>Date:</strong> By
            </li> </ul> <!-- DETAILED DESCRIPTION --> <h2 class="cuni-heading">Detailed Description</h

            lecture focuses on the contractual and financial aspects of clinical trials from the persp
            academic or hospital institution. Participants will become familiar with the main types of
            documents, including CDA, Clinical Trial Agreement (CTA), Master Agreement, Data Processin

            (DPA), Budget Agreement, ancillary agreements, and amendments. </p> <p> Particular attenti
            to key CTA provisions, especially liability and indemnification, payment terms, publicatio
            property, data protection, and contract termination. A dedicated section will demonstrate 

            effectively with CROs and Sponsors, how internal limits, fallback positions, and escalatio
            work, and will offer a “view from the other side of the table” based on practical contract
            experience with leading global CROs. </p> <p> TCPP, Fair Market Value, ABAC, start-up and 

            fees, and budget escalation will also be discussed. Practical examples will demonstrate ho
            the legal and financial position of the research site. The session will include discussion
            opportunity for questions. </p> <!-- LEARNING OUTCOMES --> <h2 class="cuni-heading">What P

            Learn</h2> <ul class="cuni-outcomes-list"> <li> An overview of the main types of contracts
            used in clinical trials </li> <li> An understanding of the key provisions of the Clinical 
            (CTA) </li> <li> Practical skills for negotiating with CROs and Sponsors </li> <li> An und

            of internal limits, fallback positions, and escalation procedures </li> <li> An understand
            financial aspects of clinical trials, including TCPP, Fair Market Value, ABAC, start-up, a
            fees </li> <li> The ability to strengthen the legal and financial position of an academic 

            institution </li> </ul> <!-- CONTACTS --> <h2 class="cuni-heading">Contacts</h2> <div clas
            wrapper"> <div class="cuni-contact-group"> <h4>Program Lead</h4> <p> Mgr. BcA. Ivo Svejkov
            MBA </p> <p> Director of the Centre for Knowledge and Technology Transfer at Charles Unive

            href="mailto:ivo.svejkovsky@ruk.cuni.cz"> ivo.svejkovsky@ruk.cuni.cz </a> | <a href="tel:+
            +420 771 128 396 </a> </div> <div class="cuni-contact-group"> <h4>Lecturer</h4> <p> Mgr. B
            Svejkovský Ph.D., MBA </p> </div> <div class="cuni-contact-group"> <h4>Contact Person</h4>

            Ivo Svejkovský Ph.D., MBA </p> <a href="mailto:ivo.svejkovsky@ruk.cuni.cz"> ivo.svejkovsky
            | <a href="tel:+420771128396"> +420 771 128 396 </a> </div> </div> </div>