Study feasibility process.
TTC has a department for the completion of study feasibility assessments within a reasonable time frame. We have detailed information on each completed study since 2000 including the name of the principal investigator, therapeutic area, screen failure rates, randomization and retention rates, for respective sponsors and CROs.
TTC aims to address the needs of the sponsor in completing clinical trials timeously and meeting the target number of participants required for each study protocol. TTC has participated in studies in a wide range of therapeutic areas and in all phases of development. The majority of studies are late phase (75%) and in adults. Since 2015 we have extended our service to conduct pediatric clinical trials, as there is a requirement for data on children prior to registration of new medicines through the Pediatric Investigational Plan (PIP).
TTC is experienced in the conduct of early phase studies (25% of studies conducted), and has a special facility for the performance of pharmacokinetic and bioequivalence studies.
Remote Data Capturing.
The collection of accurate data and prompt resolution of queries decreases the number of monitoring visits required, which in turn translates into substantial cost savings for the sponsor. Systems used: Medidata RAVE, Oracle, PhaseFoward i.e. InForm, Perceptive i.e. DataLabs, Datarak, RACE.
Patient Electronic Diaries.
Great care is taken in training of participants to use electronic diaries. Investigators have access through a portal to review off-site data acquired by participants. Systems used: Viasys (Jaeger), AM 2+, AM 3+, Biomedical Systems, Blackberry, and Trialmax portal.
Electronic Data Transfer.
TTC has the capability to transmit electronic data using a dedicated analog line. We have experience in Mortara Electrocardiogram Transfers, Medilog Holter transfers, MAC 1200, Viasys Spirometry, ECG, and electronic diary data.
Interactive Voice Response Systems.
The following systems are used for registering study visits and allocation of treatments to participants: ClinPhone, Almac, RAMOS, i-Perspective, ICON, and IMPALA.
Focus on Good Clinical Practice and Patient Education.
Investigators knowledgeable in GCP and the disease under investigation are responsible for educating the participants on their condition as well as for the Informed Consent Process. The trial centre is a friendly environment, where the well-being of participants is paramount.
TTC has a team specializing in Clinical Trial submission to Regulatory Authorities. The submissions are completed accurately according to requirements and within timelines.
Contract and Budget review.
TTC has a department for the negotiation of budget and clinical study agreements. The review time is a maximum of 2 weeks.