Trial Care International, LLC
TCIs team has the experience and expertise to provide services supporting our clients and Investigator Sites in preparing for regulatory authority inspections (Food and Drug Administration (FDA), Health Canada etc.)
Our vigorous GCP Inspection Readiness Program for clinical sites includes a “mock” inspection and a detailed plan to address findings and deficiencies. Our program provides site staff with the tools to speak to inspectors, defines roles and responsibilities for site staff prior to, during and after an inspection, sample inspection questions, and how to follow-up and respond to potential findings.
TCI offers a full range of services specializing in: protocol design, project management, investigator recruitment and selection, document collection and supply shipping, contract and grant administration, investigator meeting coordination and facilitation, monitoring, GCP auditing, regulatory submissions and strategies, biostatistics, medical writing, safety monitoring and data management.
TCI maintains a network of experienced monitors. Every one of TCI’s Clinical Research Associates (CRAs) brings two key attributes to the table: therapeutic expertise and clinical research experience. We employ CRAs with the best credentials and recommendations because we know they are critical to the success of your trial. Many of our CRAs are certified in nuclear medicine, CT, MRI or ultrasound modalities. Our CRAs perform monitoring activities to ensure compliance with the protocol and to all regulatory requirements. They are also dedicated to establishing strong relationships with our investigative sites to ensure successful study progress.
The monitors conduct pre-study site selection; site initiation, periodic site monitoring, and site close out according to designated Standard Operating Procedures. The project teams are composed based on therapeutic experience, geographic location and language requirements. We do our absolute best to maintain the same team throughout the length of the project. We will provide a dedicated team to each of our clients from project to project upon request. This provides efficiencies in both time and project costs.
TCI provides monitoring services to support any clinical trial in North America, Europe and Asia. Monitoring services in other areas of the world can be provided through select international partners. Our decentralized workforce allows us to maximize flexibility, reduce travel costs, and create an efficient and cost effective monitoring process.
TCIs medical writers have a wide range of therapeutic expertise. Medical writing services include clinical protocol and amendments, regulatory/FDA submission documents, safety narratives and clinical study reports.
TCI knows that finding the right investigators plays a key role in the success of your clinical trial. We have worked with hundreds of qualified investigators over the years and maintain an active listing from which to choose.
We ensure efficiency at study start-up by providing a comprehensive study start-up package that walks sites through collection of the required documentation for your study. We also strive to utilize investigators we are familiar with to ensure fast and efficient turnaround times for qualification and regulatory document processing.
Once a study site is selected and approved, we place a strong emphasis on building a positive working relationship with the site. Experience has shown us that constant communication and training adds to the sites' willingness to deliver quality data in a timely fashion. When these relationships are maintained, it allows us to work with investigators or sites on multiple studies, resulting in significant time efficiencies.
TCI is unique in offering specific expertise during a clinical trial by allocating resources to our clients for the duration or part of a trial. Contracting specific expertise such as regional monitors, in-house resources, project managers or administrative help can be the key to success when there is a lack of in-house staff to start up or finishing a clinical trial. Our contractors may be integrated into your study team at your offices or based regionally. This approach will enable you to be fiscally conservative while staying on track with your clinical trials.
TCI provides EDC services utilizing the Viedoc™ web based system. The Viedoc application is project specific. It will be designed according to the clinical study protocol and the CRF and is set-up for access by the study staff. Because Viedoc is available 24 hours a day, tasks such as data entry, trial management, queries, logic checks and data downloads into SAS datasets can be done at any time. The Viedoc™ system also has an integrated CTMS module where essential study documents such as protocols, IRB approvals, lab and ECG reports etc. can be stored and reviewed.
Our project Managers, CRAs and clients are able to monitor the project and study site performance while the study is running. They can send queries to further clarify entered data if necessary. With Viedoc, clinical data is available for review earlier in the study. Events, such as patient safety issues or data trends can be evaluated as they occur. This knowledge enables more timely and accurate decisions about patient safety issues.
TCI is able to provide US regulatory expertise to our local and International clients. Our regulatory services include regulatory strategy consulting, FDA communication, preparation and submission of INDs, IND maintenance and safety reporting, annual updates and NDA filings. Through our select international partnerships we are able to extend European and Asian expertise to our North American clients.
Our Statisticians and SAS programmers apply scientific principles and specific therapeutic knowledge to study design, protocol sample size and endpoint development. Our statisticians have over 20 years of experience participating in trial design and interacting with the FDA and European Medicines Agency.
TCI advises clients on how to verify the integrity of clinical data and ensure adherence to protocols, SOPs and international regulatory guidelines while continually protecting the rights and welfare of research subjects. Our quality inspections program is enhanced by our audit readiness program and includes clinical document review and system, vendor, investigator site, and database audits.
Our medical monitors have over 30 years of industry experience reviewing and reporting safety in clinical trials. We also provide trend analysis, pharmacovigilance and database management and monitoring. Additional services include the establishment of DSMBs, development and implementation of DMSB charters, guidlines and procedures, and development of SOP’s for safety reporting.
Whether you are in pre-clinical or well into your study, TCI can add value to your recruitment strategy. With dozens of strong contacts with the top research institutions, TCI knows the ins and outs of their contracting processes, IRB/ EC approval processes, and knows the best approach to attract the ideal subject population for your study.
TCI provides international GCP audits as required for a successful, inspection-ready clinical trial. An audit plan is developed by TCI and reviewed and approved by our client prior to implementation. Audit reports and recommendations will be provided at the end of the audit and as per the audit plan the appropriate party will follow up with the site on any corrective action. TCI also provides our clients with in-house review and inspection of Trial Master Files.
At TCI, we are proud to provide the most talented and highly experienced project managers in the industry. We take their skills and enhance them with project specific training that ensures our customers truly unsurpassed service. Our project manager is your primary liaison and strives to establish a collaborative relationship with your project team. The project manager has responsibility for maintaining compliance with sponsor and project requirements, assuring project team training and performance, tracking of budget, and reporting of study progress in order to ensure that all deliverables are met. They are committed to maintaining flexibility and cost management. As the leaders of a multidisciplinary team, they are empowered to manage every aspect of a trial and handle new objectives as they arise.
The project manager can aid in the development of the clinical protocol, draft a template Informed Consent Form and negotiate contract and budgets with sites and other vendors. The project manager will coordinate the start-up of the project and oversee all aspects of the project through completion. A detailed project plan is developed at the beginning of the study, which outlines in detail the responsibilities, timelines and deliverables.