Chiron Medical CRO Study Start-Up Services

Clinical Trial Feasibility Assessment​

To enable sponsors to start their studies as soon as possible, Chiron Medical has streamlined its study intake procedure. Chiron Medical determines the operational capabilities, trial budgets, and human resources needed for incoming clinical trials in order to develop a comprehensive study plan. In order to guarantee that the study is carried out at the right sites, this entails evaluating site placement strategies and lead reviews. We create and facilitate the completion of Feasibility Questionnaires (FQs) to verify that the site’s capabilities satisfy the requirements of the study. The FQ data is then assessed in feasibility meetings. The Chiron Medical team performs Site Qualification Visits (SQVs) to find sites that have the patient pools and capabilities needed to comply with protocol requirements. With the use of these comprehensive feasibility reviews, the Principal Investigators (PIs) can approve the studies they plan to conduct and determine whether there is a sufficient subject pool to sustain study enrollment. These early actions are critical for carrying out a successful and compliant study.​

Start Strong, Finish Stronger: Study Launches that Define Success.

Chiron Medical: Your Gateway to Start-Up Success Through Regulatory Assessment.

Assessment of Start-up Regulatory Requirements​

Our expert team evaluates incoming studies from the beginning with regulatory implications in mind. In order to handle the numerous regulatory considerations of today’s Phase 1–Phase 2–Phase 3–Phase 4 clinical trials, medical device studies, or bioequivalence and bioavailability studies, we build sponsor study management strategies. Chiron Medical organizes, facilitates, and manages the study’s regulatory inspections. We stay up to date on the latest legislations and regulations pertaining to clinical studies so that our study management services are always supportable and compliant. From the very beginning of the project, we prepare submissions that are made to ethics committees and regulators. Throughout all clinical trials or medical device studies, Chiron Medical prioritizes adhering to the most recent regulatory and legislative requirements. ​

Development of Study Related Documents​

Chiron Medical provides assistance in development of the study-related documentation needed at every stage of the clinical investigation. Among the documents that we may support in developing or improving are, but are not restricted to:
• Study Design and Synopsis
• Clinical Trial Protocols
• Informed Consent Forms (ICF)
• Case Report Forms (CRF)
• Monitoring Plan
• Patient Reported Outcomes Questionnaires, Patient Diaries, Patient Cards and any other patient-facing materials

Chiron Medical: Elevating Studies Through Insightful Document Development.

Clinical Trial Protocol Design and Biostatistics

Each and every clinical trial is a component of a bigger program for product development. The collected data must be arranged in a way that supports decision-making and offers a quick, transparent, data-driven route to decision points. We assist our clients in calculating the right sample size, taking design decisions into account, organizing the analytic procedure, and overseeing its implementation. The right data may be provided for the sponsor and the regulator to make decisions with the support of a robust protocol design and an extensive biostatistical analysis structure. Chiron Medical uses its in-depth understanding of regulations and clinical management experience to assist sponsors in creating strong biostatistics plans and protocol designs.

Vendor Selection & Management​

A crucial and time-consuming component of starting any clinical research management program is vendor management. The first administrative tasks required to launch any clinical study include vendor selection, contract negotiations, and project management tasks. This administrative load is carried by the vendor managers at Chiron Medical for our sponsors. You don’t have to be concerned about keeping an eye on the timely delivery of high-quality work from several subcontractors. For you, Chiron Medical handles them all with ease. This isn’t limited to the beginning of the investigation. We oversee vendors during the study to guarantee a streamlined and uniform procedure for every sponsoring organization. Chiron Medical streamlines the process of managing vendors.​

Site Budget and Contract Management​

Chiron Medical can expedite the initiation of your crucial clinical study by utilizing its robust connections with top specialists. We employ well-established, standardized contract templates for both legal and financial conditions, which speeds up site talks and helps us get agreements more quickly. The contract process is streamlined for you by Chiron Medical Contract Managers by:

  • Providing investigator budgets for site review
  • Creating and examining site-specific budget plan, contracts, and other paperwork particular to the site
  • Administering all contract management procedures, including coordination of relevant protocols, Informed Consent Forms (ICF), departments, investigators, and subcontractors
  • Keeping contracts on schedule.
  • Managing basic financial aspects of the project
  • Communicating with the legal, finance, and clinical operations departments, both internal and external