SCIENTIFIC ARTICLES

The articles listed below were authored by SGS’s premier scientific staff on key industry topics. If you have any questions about the content please feel free to contact the author directly through the email link located at the end of each article.

Clinical Pharmacology

• Ensuring Optimal Quality of a Thorough QT Study
• Conducting a First-In-Human Trial In Light of the 2007 EMEA Guideline
• Volunteers’ Inclusion Period Check (aka VIP Check)
• Improving Drug Development Through Exploratory-IND / Early Phase 1 Studies
• ADME Studies: 14C Medication
• Working In Clinical Pharmacology: An Interview
• Executing Exploratory Clinical Development Studies

Bioanalysis

• A Vaccine Bioassay Case Study
• Crystal City III: Incurred Sample Reanalysis: Not If But How
• Applications and Advantages of Flow Cytometry in Clinical Research

Late Phase Development

• Management of a Complex Proof of Concept Study
• Innovative Clinical Solutions to Improve Recruitment
• Conducting Successful Multicentre Clinical Trials in Central and Eastern Europe
• HIV Clinical Trials: Recent Changes In The Environment
• The Indispensable CRA

Data Management

• From CDASH in Central Designer^TM and Inform^TM to SD^TM
• The ABC’s of a DMC
• EDC and CDISC, the Perfect Combination for Successful Submission
• Time To Implement Edc For Phase I Trials?

Regulatory Affairs

• Readability of The Package Leaflet
• Orphan Drugs Favourable Regulations Benefit Biotech

Pharmacovigilance

• Changes to EU Pharmacovigilance System