Biostatistics

Trail Clin Technologies biostatisticians work with clients to determine methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs.

• Statistical review of protocol and CRF
• Power and sample size calculations
• Randomization schedules
• Data Integration and Mining
• Statistical Analysis Plans (SAP) creation/review
• Statistical review of protocol and CRF
• Power and sample size calculations
• Randomization schedules
• Data Integration and Mining
• Statistical Analysis Plans (SAP) creation/review
• Statistical review of protocol and CRF
• Power and sample size calculations
• Randomization schedules
• Data Integration and Mining
• Statistical Analysis Plans (SAP) creation/review

Statistical Programming

Trail Clin Technologies Statistical programmers have years of SAS® Programming expertise, allowing them to complete the programming task accurately and in a timely manner.

• CDISC Conversion (Mapping to SDTM)
• Generation of Analysis Datasets (ADaM)
• Generation of Tables, Listings and Figures/Graphs
• Validation of Data
• Creation of CRT Packages (Reviewer’s guide; Define.xml, Patient Profile)

Clinical Data Management

Trail Clin Technologies provides a full range of data management services from Phase I through to post-marketing trials, upholding a standardized, process-driven approach. Trail Clin Technologies has also developed proprietary tools and standards to work with these products to further enhance the process and provide our clients with a streamlined and efficient approach to data management that results in a quality end product. We focus on designing, building, and deploying clinical trial databases faster, more effectively, and efficiently.

• EDC and Paper Trial Set-Up & Management
• CDASH Compliant deliverables
• Data Management Plan (DMP) development
• CRF/eCRF design and development
• CRF Annotation & Review
• Database design, creation, and maintenance
• UAT Testing
• Data validation specifications
• Edit checks Programming & Testing
• Query Management
• Medical Coding
• SAE Reconciliation/ Lab Reconciliation
• Database lock activities

Pharmacovigilance and Drug Safety

Trail Clin Technologies offers drug safety and risk management services for pharmaceutical, biotechnological, and medical device companies to ensure timely submission of quality adverse event data to various regulatory authorities across the globe. Trail Clin Technologies' Pharmacovigilance teams possess the knowledge of local regulations, standards of care, and cultural customs needed to identify and assess risks during clinical trials, safeguarding the subjects' safety.

• Case coding and Narrative writing
• Safety Database Services
• Individual Case Reporting
• Aggregate Safety Reports
• Periodic Safety Update Reports (PSUR),
• Benefit-risk evaluation report (PBRER)
• Periodic Adverse Drug Experience Report (PADER)
• Developmental Safety Update Report (DSUR)
• Investigational New Drug (IND) – Annual Report
• Safety/ Risk Management Plan (PSUR),
• Signal Detection and analysis
• Adverse event and Product Complaint Management

Regulatory Affairs

Trail Clin Technologies offers proven solutions and exceptional quality, ensuring successful delivery of regulatory services from locations around the world. Our regulatory affairs experts help navigate the entire drug development and regulatory submission process to meet regulatory goals.

• Regulatory consulting
• Clinical Development Plan
• Regulatory eCTD dossier preparation, publishing and submission
• Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD)
• Global submission management and report publishing creation/review
• Medical writing
• License maintenance for marketed products
• Technology assessment,
• Regulatory Labelling and Liaising
• Global Regulatory guidance and support

Quality Assurance

Trail Clin Technologies offers a fully compliant and high-quality complete package of quality assurance services. From outsourcing of individual activities to the setup and management of an effective and efficient global quality system, Trail Clin Technologies provides solutions specific to the requirements of our customer’s organization and products.The Trail Clin Technologies quality team ensures planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies.

• Validation Planning & Design Assessment and Monitoring
• On-Site Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) Training
• Quality Management Systems
• GCP/ICH compliant processes
• CAPA (Corrective and Preventive Actions)
• Quality Management Reviews and Quality Audits
• Quality System Regulations / ISO standards
• Review and Validation of Technical Documents

Information Technologies and Consulting

Trail Clin Technologies offers a comprehensive range of strategic IT consulting and infrastructure-managed services tailored to support distributed and hybrid IT environments. Embracing an ITIL-driven methodology, we ensure a deep understanding of our clients' needs, fostering exceptional outcomes and facilitating business transformation for global organizations.

our expertise lies in delivering comprehensive enterprise application services. This encompasses integration, customization, rigorous testing, thorough training, meticulous documentation, and ongoing support and maintenance. Our service suite covers the following areas:

• Package Implementation
• Support and Maintenance
• Enterprise Application Development
• Integration
• Cloud Solutions