-
Document development |
We assist in the preparation of all required study documents, including the study protocol and participant information documents, ensuring clarity and compliance with regulatory standards, while also supporting a smooth and efficient approval process.
We draft committee charters, electronic Case Report Forms (eCRF) in alignment with protocol requirements, and develop study-specific Standard Operating Procedures (SOPs), guidelines, and logs. |
Trial Master File setup and maintenance |
We set up and maintain the Trial Master File, keeping all study documentation organized and up to date to support regulatory compliance and inspection-readiness. |
| Submissions to ethics committees and regulatory authorities |
We manage the submission process to obtain approvals from ethics committees and regulatory authorities in Switzerland and internationally, actively assisting with responses to authority questions and requests during the approval process. |
| Ethics and regulatory reporting during study conduct |
We manage ethics and regulatory reporting throughout the study, including preparing annual (safety) reports for Switzerland and internationally, and ensuring compliance with reporting timelines. |
| Clinical Trial Registry Management |
We manage the initial registration and updates of the trial on platforms like ClinicalTrials.gov and other international study registries. |
| Site management |
We facilitate site onboarding, including feasibility assessment, site contracting, and initiation, and work closely with participating sites throughout the study to provide support, guidance, and coordination to ensure smooth operations. |
| Stakeholder and vendor management |
We coordinate and serve as the central point of contact for all study stakeholders, including investigators, study sites, patient advisory boards, and external service providers, ensuring clear communication, aligned expectations, and efficient collaboration. |
| Recruitment and enrollment oversight |
We monitor participant recruitment and enrollment progress across study sites, identify potential challenges, and propose targeted recruitment support strategies to facilitate timely and effective recruitment. |
| Quality management and ongoing compliance oversight |
We oversee study conduct and documentation, ensuring adherence to GCP and regulatory standards. We review monitoring reports and key monitoring outcomes, evaluate identified issues and risks, and propose appropriate corrective and preventive actions in coordination with the relevant stakeholders. |
| Investigational product supply chain coordination |
We oversee the investigational product logistics, including supply planning, distribution, and accountability, in collaboration with all relevant stakeholders. |
| Biological Sample Management |
We coordinate arrangements with biobanks, including defining sample collection methods, storage and transport requirements, and monitoring adherence to agreed procedures. We also manage associated budgets and logistics, review site sample management activities, and ensure sample integrity, traceability, and readiness for downstream analyses. |
| Timeline and budget management |
We monitor project timelines and budgets to ensure the study stays on track and within financial constraints, enabling successful and timely completion. We engage with study sites to negotiate timelines, resource allocation, and budget consideration. |
| Project
status reporting |
We provide regular updates on study progress, key milestones, and critical issues, keeping you and other stakeholders informed throughout the study. We prepare and submit periodic reports to funding agencies, ensuring transparency, and alignment with study objectives and contractual obligations. |
| Risk management |
We identify potential risks to study success and propose mitigation strategies to ensure smooth operations and adherence to regulatory requirements. |
