Knowledge Management
XenoTech’s Knowledge Management group focuses their efforts on providing efficient, high quality document and reference material services in support of contract studies and products production.
The Knowledge Management Group contribute expertise and support to:
Preparation of contract study reports meeting our sponsors’ documentation requirements and
ICH eCTD specificationsElectronic Common Technical Document (eCTD) is a technical specification developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for the purpose of providing criteria for industry when transferring product registration information in electronic format to the applicable regulatory agency. XenoTech follows eCTD specifications when preparing contract service reports.
To learn more about ICH, visit their website at www.ich.org.
The latest version of the eCTD specification (PDF).
Archiving and maintenance of facility and contract study records meeting applicable regulatory requirements
Control and management of SOPs and data recording forms
Management and acquisition of scientific reference materials