Identifying and evaluating potential clinical trial sites based on their capabilities, experience, patient population, and infrastructure. This includes conducting feasibility assessments to determine the site's suitability for the study.
Conducting initiation visits to prepare sites for the study. This involves training site staff on the protocol, procedures, and regulatory requirements, as well as ensuring that all necessary documentation is in place.
Assisting sites in obtaining necessary regulatory approvals and ensuring compliance with local and international regulations, including ethics committee approvals.
Regularly monitoring site activities to ensure adherence to the study protocol, GCP, and regulatory requirements. This includes routine monitoring visits to assess data integrity, participant safety, and overall site performance.
Providing ongoing training and support to site staff, including Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other personnel, to ensure they are knowledgeable about the study and their responsibilities.
Implementing strategies to enhance patient recruitment and retention at the site. This may involve outreach efforts, community engagement, and patient education initiatives.
Ensuring accurate and timely data collection and reporting from the site. This includes overseeing the completion of case report forms (CRFs) and ensuring data quality.
Identifying and addressing any issues or challenges that arise during the trial, including protocol deviations, adverse events, and site performance concerns.
Conducting close-out visits at the end of the study to ensure that all study activities are completed, documentation is finalized, and investigational products are accounted for.
Assisting sites with the proper archival of study documents and data in compliance with regulatory requirements for record retention.
Design and conduct of studies to evaluate the rate and extent of drug absorption for new formulations.
Comparative studies to demonstrate therapeutic equivalence between test and reference products.
Conducting studies under both fasting and fed conditions as per regulatory requirements (USFDA, EMA, DCGI).
Implementation of 2-way, 3-way, and 4-way crossover designs for robust comparative assessment.
Feasibility studies followed by full-scale pivotal studies for regulatory submission.
Evaluating the impact of food on drug absorption and bioavailability.
Studies comparing different formulations (tablets, capsules, liquids, injectables, topical products)
Evaluating pharmacokinetic interactions between co-administered drugs.
LC-MS/MS and HPLC methods for accurate drug quantification in biological matrices.
Calculation of Cmax, Tmax, AUC, t½, and other PK parameters for regulatory submission.
Preparation of BE study reports and documentation for USFDA ANDA, EMA, DCGI, and other global filings.
Sample analysis using LC-MS/MS, HPLC, with GLP-compliant workflows and audit trails.
Secure long-term storage of biological samples with 24/7 temperature monitoring and backup power.
Ensuring adequate washout between study periods for crossover designs.
Preliminary studies to guide dose selection for pivotal BE studies.
Trialcraft maintains a fully equipped diagnostic laboratory within our 32-bed BA/BE facility to support real-time subject safety monitoring and screening.
