Services > Scientific Affairs

Pharmacokinetics

• Pharmacokinetics (PK) and Pharmacodynamic (PD) study designs
• PK/PD modeling
• Non-compartmental and compartmental, PK/PD, and population PK analyses

Biostatistics

• Sample size and power calculations
• Randomisation schemes
• Development of sophisticated statistical analysis plans (SAP) including Mock Tables, Listings and Figures (TLFs)
• Statistical programming and data analysis for PK, PK/PD, efficacy, and safety endpoints
• CDISC compliant SAS Export Package
• Statistical consultation and education
• Ad hoc and retrospective analyses

Data Management

• Electronic Case Report Form (eCRF) design and development
• Database design & validation
• Data management & validation plan preparation
• Coding of AEs & concomitant treatments
• Data entry validation, tabulation, control & clarification
• Database lock
• Data Clarification Form (DCF) Management

Medical Writing

• High quality data presentation & writing in accordance with global regulatory standards with sophisticated planning and execution
• Experienced-based study protocol & ICF development
• Integrated study report writing in eCTD format with hyperlinking & bookmarking
• Preparation of FDA Summary Tables for ANDA submissions
• Custom format reports
• CD-ROM copy and hard copy of reports and associated study data
• CS-BE preparation for TPD submissions
• Compilations of abstracts, manuscripts, publications & poster presentations

The integrated study report is the final deliverable that is provided to the clients, serving the goal of issuing the report in the shortest time possible.
Our standard reports are prepared to conform to the requirements of the ICH E3 "Structure and Content of Clinical Study Reports". Past experience and regulatory expertise ensures that reports are written to minimise any possible delay in regulatory approvals.

Regulatory Affairs

• IRB Submissions
• CTA preparation & filing
• Liaise with the IRB
• Import & Export and investigator use permits preparation for controlled substances and Class A precursors
• Consultation with regulatory agencies (US FDA, TPD, EMA)