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.


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