Working for you
Our skilled and well-trained clinical staff ensures the highest quality work typically managing one protocol at a time to offer customized services and keep study timelines always on track.
Due to the high pressure towards cost-effectiveness today's markets demand, we streamline our processes and services to ensure our clients get the most out of their budget.
Our team of experts will assist you through each step of clinical development and regulatory stages (pre- and post-submission).
ITClinical's monitoring staff identifies the best investigational sites for your study and provides the management and the necessary support.
A Feasibility Study adapted to the clinical trial design and the therapeutic area can be performed by us in a short period of time, followed by Site Selection and Qualification Visits in order to initiate the clinical trial as quickly as possible, minimizing the pre-study period.
Clinical Trial Setup
ITClinical's experienced team can take care of the Ethics and Regulatory Submissions of your clinical trials. We can provide full package submissions and meet crucial ethics and regulatory timelines. Our Language Affairs team can also help you translate and localize your documents.
The study documentation not only has an important role during the Clinical trial submission phase, but it is also essential during all the Trial. Maintaining an accurate and updated Trial Master File Management will always be a concern to our team.
We can also assist you with the organization of Investigator Meetings. Did you know that Portugal has been considered to be the #1 in the Top 10 countries for 2013 by Globe Spots?
Our team will perform all the site visits from Site Initiation Visit to the Close Out Visit. All visits will be reported to keep the Sponsor updated on the investigational site progression.
We can optimize this process by using our proprietary CTMS tool.
During all the monitoring visits the Clinical Research Associate will review all the study documentation performing Source Document Verification, collect Drug/Device Safety information and will carefully perform Drug/Device Accountability and Trial Supplies Verification.
The scope of compliance in clinical trials (including bioavailability/bioequivalence trials) has become wider, as the concern to ensure best practice is followed by clinical and bioanalytical sites raises. It is the sponsor’s responsibility to safeguard compliance in clinical and bioanalytical sites and ITClinical can help you do so!
Our team of experienced monitors/auditors offers a wide range of services including: - Monitoring/auditing of bioanalytical sites in (phase I and BA/BE studies)- Clinical trial monitoring (phase I to IV, including BA/BE studies)- Clinical trial auditing (phase I to IV, including BA/BE studies)
We check for compliance with the strictest EU guidelines and regulations, including Good Clinical Practice, Good Laboratory Practice, Guideline for Investigation of Bioequivalence and Bioanalytical Method Validation, among others.
Third party GCP audits
A systematic and independent examination of trial related activities and documents is of critical importance to ensure standard operating procedures (SOPs), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and the applicable regulatory requirement(s) were complied with during clinical trials.
Independence is essential for audits to reach its goals and monitors are often focused on trial-specific activities and cannot therefore assess the robustness of quality and compliance systems.
Our team offers auditing services ranging from phase I (including bioavailability/bioequivalence trials) to late phase and a full package (from audit planning to reporting and even Corrective Action/Preventive Action accompanying) is available.