Services

CTC Team performs Investigators identification per particular Clinical Study in a very short time. According to the Sponsor’s needs we develop feasibility materials to assess the possibility of potential Clinical Study Sites to take part in a particular Clinical Study or review feasibility materials provided by the Sponsor and create feedback with suggestions and recommendations which will facilitate the Investigator selection process in a particular Clinical Study. We also perform face-to-face or remote Pre-Study Site Selection Visits to ensure that a potential Principal Investigator is qualified and interested in conducting the Clinical Study, the Clinical Study Site has adequate facilities and resources to properly complete all required study activities, as well as required pool of subjects to complete enrollment. Each Pre-Study Site Selection Visit is carefully planned, conducted and reported in written in accordance with Sponsor’s requirements and expected timelines.

We provide templates of each type of contract. We offer negotiations both on CTC or Sponsor template all the terms and conditions with Principal Investigators and Investigational Sites’ attorneys to reach a consensus within a reasonable time frame.

We offer the preparation of the complete clinical trial dossier and perform initial submissions to Regulatory Authorities and Central Ethics Committee via CTIS in case of drug studies as well as to Regulatory Authorities and Independent Ethics Committees in case of device studies. Service also includes responding to potential deficiency letters received from authorities and ethics committees. Moreover, we prepare dossiers and perform submissions to regulatory bodies with the purpose of obtaining approval of substantial amendment(s) for Clinical Study. We prepare and perform all types of notifications and non-substantial modifications to regulatory bodies during the conduct of Clinical Trial (e.g. Start of the Clinical Study, First Subject In, End of Study notification, Clinical Study Report notification etc.). On behalf of the Sponsor we also conduct periodic Clinical Study status reporting. We administrate and processing all required payments to applicable regulatory bodies for their expertise of submitted Clinical Study Documentation. We report all serious violations of Good Clinical Practice or the Clinical Study Protocol to the regulatory bodies as required. Where necessary, we providing ongoing communication with Regulatory Authorities, Central/Independent Ethics Committee during the conduct of Clinical Trial. We inform regulatory bodies of the Study Completion and provide them with the Final Study Report.

We are able to obtain country specific Clinical Study insurance. In case of global insurance provided by the Sponsor we offer its review and adaptation to country specific requirements.

CTC Team offers experienced Clinical Research Associates and Project Managers based in Poland who are able to perform on-site and in-house monitoring as well as management services in phases of clinical trials of Investigational Medicinal Products and Medical Devices. Monitoring and management services can be conducted according to SOPs of CTC Team or/and SOPs of our Sponsors, depending on their requirements.

Start-up Phase

We collect Investigators and Sites regulatory documents necessary for submissions to regulatory bodies.

We distribute all required Clinical Study Documents to the Sites.

We organize local purchase of equipment and/or materials necessary for Clinical Study conduct or support of Sponsor in this activities. We support the Clinical Study Sites in completion of all required trainings necessary for Site activation. We can find required courses for Site Staff or perform necessary trainings for Clinical Study Sites as required.

We prepare initial shipment of necessary study supplies and documentation like Investigator Site File, Pharmacy File, blank templates of Patient Information and Informed Consent Forms, Patient Emergency Cards, Patient recruitment materials, Patient Questionnaires and Diaries, equipment and materials etc. to Clinical Study Sites.

Study Conducting Phase

We start the study conducting phase with Site Initiation Visits to ensure that the Principal Investigator and the Site Staff are familiar with the relevant study documentation, procedures and responsibilities as outlined in applicable regulations, as well as with Investigational Medicinal Product or Medical Device and administrative procedures. the Principal Investigator and the Site Personnel are ready to meet the Sponsor's requirements regarding informed consenting and the conduct of any screening activities. These visits let to ensure the Clinical Trial Sites have adequate facilities and resources to properly complete all required study activities. Site Initiation Visits can be performed face-to-face or remote, they are planned, conducted and reported in written respecting the agreed with Sponsor timelines and expectations.

During whole study conduct phase takes place ongoing communication with Clinical Study Sites and issue resolution. Regularly discuss topics include, but are not limited to: patients enrollment rate, Protocol related inquiries, opened action items, safety events and their management, Clinical Study equipment, materials, supplies and documentation.

We perform face-to-face or remote Interim Monitoring Visits to verify that:

• the rights and well-being of human subjects are protected,
• reported clinical study data are accurate, complete, and verifiable from source documents, course of the study stay in compliance with
• the approved protocol and amendments, ICH GCP guidelines and applicable law regulations
• facilities and Site Staff remain acceptable for the conduct of the Clinical Study
• Investigational Medicinal Products or Medical Devices are stored as required and the facility is adequately stocked
• the timelines for patient enrollment, Case Report Form completion, Data Clarification Form and query resolution are met.

Each Interim Monitoring Visit is carefully planned, conducted, reviewed and reported in written in accordance with Sponsor requirements.

We management of Clinical Study changes at both Study and Site levels following the issuance of Clinical Study Protocol Amendments and other related changes.

We support of Sponsor and Clinical Study Sites in safety events management (e.g., reporting of serious adverse events, events of special interest etc.) and ensure that all regulatory reporting requirements for occurred safety events are met.

We care about re-supply of Sites with study materials and supplies necessary to effectively conduct Clinical Study.

We process of payments to Sites as per executed Clinical Trial Agreements if CTC is responsible for payments or support Sponsor in processing all payments.

We are responsible for reporting and management of Clinical Study Protocol Deviations, if any. We maintenance of Trial Master File, perform its quality review and check, resolution of all related action items.

Close-out Phase

We perform Site Close-out Visits to formally document the completion of the Clinical Study. These visits can be performed face-to-face or remote. Visits are designed to confirm all Clinical Study documentation is available and can be archived, confirm resolution of data queries, verify that the Principal Investigator understands post-study obligations. Each Site Close-out Visit is carefully planned, conducted and reported in written respecting the agreed with Sponsor timelines and requirements.

We also conduct post Close-out activities. We support the Investigational Sites in receipt of final completed Case Report Forms for archiving and in return of supplied Investigational Medicinal Product or Medical Device, study equipment (as applicable) and finalization of corresponding supporting documentation. We assist Sponsor and the Sites in processing the final payment as per executed Clinical Trial Agreements. We also support the Sponsor in providing the Sites with Final Clinical Study Report and all documentation confirming report completion of the study to the regulatory bodies.

We select, contract and manage third party vendors required for a particular Clinical Study like local diagnostic specialist laboratories, local depots for storage and distribution of Investigational Medicinal Products or Devices etc. We propose to Sponsors the services of our vendors and their respective management if approved by Sponsor.

Depending on the Sponsor's requirements we can review of drafts of Case Report Form provided by the Sponsor, perform user acceptance testing of Case Report Form and create feedback with suggestions and recommendations. We also can organize construction of Electronic Case Report Form for each individual study by vendors we routinely cooperate in this matter. If required we perform and document site training on the use of Case Report Form.

We cooperate with Sponsor’s QA Department to ensure overall Clinical Study compliance with applicable quality standards and oversee, approve and support management of corrective and preventive actions as applicable.

At the Sponsor's request we perform Co-Monitoring Visits and Site Audits, both face-to-face and remote to verify that the Clinical Study Site Staff work according to the Sponsor expectation, Clinical Study Protocol, Regulatory and ICH GCP requirements. Each Co-Monitoring Visit and Site Audit are carefully planned, conducted and reported in written respecting the agreed with Sponsor timelines and requirements