Our Services.
Regulatory Start-up
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 • Customisation of strategic regulatory plan to accelerate submission timelines • Constant monitoring of the regulatory environment in SG to speed up HSA approval • Provision of regulatory consulting services
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 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 • Data transfer • Quality control • Database lock • Electronic archival • Database transfer
Quality Assurance
Clinical Operations
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 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 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
Project Management
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. We also celebrate milestones together with our partners. Our committed and dedicated project manager are the single point of contact for each project, with vast experience to cover all therapeutic areas and indications across all clinical development phases. Your success is ours too.
Site Management
Medical Writing
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 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 optimise 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
CRA, CRC, and CTA Training
We believe that quality employees are the most important asset. We provide training services aimed at CRAs, CRCs, and CTAs to improve their skills, enhance their productivity, and develop their portfolio. We designed our courses with relevance in mind, focusing on putting theory into practice. Our trainings are highly interactive and filled with case studies. The trainings can be customised based on your organisation’s needs. CSI Medical Research provides the following services under Training: • CRA onboarding training • CRC onboarding training • CTA onboarding training • Development of training materials
Clinical Biostatistics