We're committed to Safe & Protected Clinical Trials for our Patients.
Our Services.
Regulatory Start-up
Our start-up teams have extensive experience in working with authority and strategically plan for submission to meet project timelines. CSI Medical Research provides the following services under Regulatory Start Up: • facilitate core regulatory dossier in accordance to applicable regulatory requirement • provide clinical input/ support in responding to agency questions • Customized strategic regulatory plan to accelerate submission timelines • Constantly monitoring the regulatory environment in SG to fast HSA approval • Provide consulting service aligned with agency thinking
Data Management
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 Data Management Plan -Providing the 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 -Data Transfer -Quality Control -Data Base Lock -Electronic Archival -Database Transfer
Quality Assurance
Clinical Operations
CSI 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 requirement 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 managements. The scope includes: Site contract and budget negotiation Regulatory and Ethic submission Site Selection Site Initiation Site/Remote Monitoring Study Close Out
IP Management
Medical Monitoring
Medical monitors are part of the study team who has the responsibility of ensuring the safety of subjects in a clinical trial, as well as providing medical expertise and input 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 in the preparation of final study reports and other study documentation
Project Management
Our Project Management orchestrated 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 meeting project goals and celebrate milestones together with our partners. Our committed and dedicated Project Manager is the single point of contact for each project, with vast experience to cover all therapeutics and indication across all clinical development phases. Your success is ours too.
Site Management
Medical Writing
With tighter regulations by authorities, transparent drug development and clinical trial documentation; Medical Writing has become more necessary than ever. A team of competent medical writers can help ensure the drug development and authorisation 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)
Pharmacovigilance
Pharmacovigilance Services is to support our customers to optimize patient safety solutions in clinical trials and post-approval safety services across the product life cycle. CSI-MR delivers pharmacovigilance solutions through expert teams who are highly skilled medical and safety professionals to achieve the safety goals of the 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
CRA & CTA Training
We believe that quality employees are the most important asset. We provide training services aim at CRA and CRC to improve their skills, enhance their productivity and develop their portfolio. We design our courses with relance in mind and focus on putting theory into practices. Our trainings are highly interactives filled with case studies discussion. The trainings can be customized based on your organizations’ needs. CSI Medical Research provides the following services under Training: -CRA Onboarding Training -CRC Onboarding Training -CTA Onboarding Training -Development of Training Materials
Clinicial Bio Statistics