Services

Strategic Consulting

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).

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

Site qualification visits.
Site initiation visits
Routine clinical site monitoring (on-Site and remote) and site close-out visits.

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.

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.

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).

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.