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CSI Medical Research provides a comprehensive range of services which cater to various aspects of clinical trials with high accuracy, timeliness, and compliance with ICH-GCP and applicable regulatory requirements. Our team of dedicated and trained CRAs, regulatory start-up specialists, and project managers provide overall support to trial sites to enable successful project delivery and risk management. The scope includes: • Site Contract and Budget Negotiation • Regulatory and Ethics Submission • Site Selection • Site Initiation • Site/Remote Monitoring • Study Close Out

Quality Assurance (QA) focuses on ensuring that products or services meet established quality standards and requirements. The primary goal of QA is to prevent defects and errors in products or services before they are released to the market or delivered to customers. QA involves a wide range of activities, including but not limited to reviewing and analyzing product design and development processes, identifying potential quality issues, conducting inspections and audits, implementing quality control measures, and testing products or services for compliance with established standards.

With tighter regulations by authorities, coupled with the need for transparent drug development and clinical trial documentation, medical writing has become more necessary than ever. A team of competent medical writers can help ensure that the drug development and authorization process is as frictionless as possible. Services provided by CSI Medical Research include the following: • Clinical Trial Protocol • Investigator Brochure • Clinical Study Report • Journal Article Publication support • Common Technical Document (CTD)

Our project managers coordinate within all related functional services to provide the best solution to our partners in delivering their projects from start to end. We deliver with confidence in quality, ensuring project goals are met. Our committed and dedicated project managers are the single point of contact for each project, with vast experience to cover all therapeutic areas and indications across all clinical development phases. We also celebrate milestones together with our partners—your success is ours too.

Medical monitors are part of the study team who have the responsibility of ensuring the safety of subjects in a clinical trial. Medical monitors also provide medical expertise and inputs into the design, operation, and analysis of a clinical trial to ensure the integrity of the trial. Services provided by CSI Medical Research include the following: • Protocol Design Consultation • Development of Medical Monitoring Plan • Study Protocol Training • Medical Support for Clinical Trial • Evaluating Adverse Events • Medical Consultation for the Preparation of Final Study Reports and Other Study Documentation

Feasibility is a crucial part of a clinical trial that determines the possibility of conducting a clinical trial in a particular geographical region, country, and clinical site, with the overall objective of optimum project completion in terms of timelines, targets, and cost. Services provided by CSI Medical Research include the following: • Site Identification and Selection • Patient Recruitment Number • Regulatory Support • Budget and Timeline Management

Clinical Biostatistics utilizes statistical methods to analyze and interpret data obtained from clinical research studies. It involves designing studies, selecting appropriate statistical methods, and analyzing data to draw conclusions about the safety and effectiveness of new drugs, medical devices, and other healthcare interventions. Clinical Biostatistics cover a broad range of activities, including sample size determination, statistical analysis planning, data analysis, and interpretation of results. It also involves providing guidance on study design and protocol development, developing statistical analysis plans, and ensuring that the statistical methods are appropriate for the study objectives and the nature of the data.

Pharmacovigilance services (PV) is to support our customers to optimize patient safety solutions in clinical trials and post-approval safety services across the product life cycle. CSI Medical Research delivers pharmacovigilance solutions through expert teams, which consists of highly skilled medical and safety professionals, to achieve the safety goals of our customers. The serious adverse event (SAE) reports are collected, processed, and stored in the latest Oracle Argus safety database, which is a powerful AI platform for safety data processing. We provide the following scope of services in PV: • Individual Case Safety Report (ICSR) Processing and Reporting • Narrative Writing • Medical Review • Safety Report Distribution and Submission • Argus Safety Database • Pharmacovigilance Training • Aggregate Report Writing – PSUR/DSUR, Quarterly or Annual Safety Report Preparation • Reconciliation of Safety and Clinical Database • Safety Management Plan

Our start-up teams have extensive experience in working with authorities and strategically plan for submissions to meet project timelines. CSI Medical Research provides the following services under Regulatory Start-Up: • Facilitate preparation of core regulatory dossier in accordance with applicable regulatory requirements. • Provision of clinical input/support in responding to queries from regulatory agencies. • Customization of strategic regulatory plan to accelerate submission timelines. • Constant monitoring of the regulatory environment to speed up regulatory approval. • Provision of regulatory consulting services.

Data management is the collection, storage, preparation for evaluation, extraction, and archiving of data collected according to a clinical trial protocol during the conduct of a clinical trial. CSI Medical Research provides the following services under Data Management: • Setting Up of Data Management Plan • Providing of Electronic Data Capture (EDC) System (Medidata, Viedoc, Taimei) • Designing of Electronic Case Report Form (eCRF) • Design of Database (build and testing) • Data Capture/Entry • Discrepancy Management • Data Coding (using MedDRA) • Data Review/Data Validation • SAE Reconciliation • Quality Control • Database Lock • Electronic Archival • Database Transfer

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