Services
Strategic Consulting
Insights and access to global markets
- Identifying local healthcare product shortages.
- Determining disease incidence rates as a result of inferior health care products.
- identifying barriers to innovative healthcare product access (price, supply, registration).
Accelerating innovative product development
- Evaluating the acceptability of protocols necessary to conduct a clinical trial.
- Database access including disease incidence statistics for the emerging markets.
- Database access containing acceptable patient demographics for the emerging markets.
- Proposing clinical trial destinations that lead to a relevant regulatory pathway.
- Proposing ROI-generating solutions based on clinical trial investments.
- Providing competitor data in terms of product use and pricing.
- Formulate a post-trial strategy (follow-up, registration and localisation strategies).
Clinical Trial Management
Clinical Operations
- Site qualification visits.
- Site initiation visits
- Routine clinical site monitoring (on-Site and remote) and site close-out visits.
Agile Project Management
- Single point of contact for clients.
- Utilise contemporary agile scrum approaches that generate faster and more significant client value..
- Are proactive, knowledgeable, experienced, and trained to work in a workplace that is complex and always changing.
- Deliver real-time project progress reports.
- Protect investments by proactively managing risks, budgets, and deadlines.
Quality Assurance
Quality Management
- Implementation and maintenance of an ISO-9001 compliant QMS.
- Preparation and assistance for regulatory inspections for Clients.
- Audits of Investigator Sites, Audits of Vendor Qualification, Audits of the TMF, and Audits of Pharmacovigilance.
- Providing quality assurance services to support customer projects.
- Contributions to the project risk management plan.
Medical & Regulatory Affairs
Medical Affairs
- Provide medical and scientific input for the identification and feasibility analysis of new countries and investigational sites, as well as the preparation of RA/IEC submission.
- Assurance of the scientific and medical validity of study design and implementation.
- Provision of medical oversight to ensure subject safety is priority (24 hr. coverage).
- Management of ICSRs (individual case study reports).
Regulatory Affairs
- Execute international and regional strategy and contingencies for assigned projects.
- Preparation and review of regulatory filings to support international marketing applications and post-approval products: e.g. NDAs, INDs, CTAs.
- Preparing, submitting and following up on initial/amended RA and Central IEC required in the country(s) efficiently.
- Review of internal and external safety and efficacy documents such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Signal Evaluation Reports (SER), Clinical Overviews (CO), HA Safety notifications, and follow up on potential CCDS/CSI changes.
Site Management
Feasibility
- Country and site level feasibility.
- Detailed investigator and site selection process.
- Assessment of potential recruitment targets and timelines.
- Focus on the rights, safety and well-being of patients.
- Strict adherence to protocol, ICH-GCP and local regulations.
- Comprehensive training of investigators and site staff.
Training
Internal Training
- Corporate Induction Programme.
- Role-based SOP Training.
- On-the-job Training.
- Annual Training Plan.
- Individualized Development Plans.
- Project Specific Training.
External Training
- Collaborations with
- Pan-Asian Clinical Research Association.
- CRA Academy (CPD).
- Investigator and site training.
- Regulatory Authority training.
- Central and Local Ethics Committee training.
