Clinical Trials

Phase I - III

Novotech’s registration clinical trials services are designed specifically for the sponsor with no local presence in the countries in which we operate. Our turnkey solution means all facets of a trial are covered by the one contract, including third party vendor management and local site agreements. Specifically the services provided by Novotech include the following:

• Feasibility assessment and site selection
• All IRB and regulatory approvals required to conduct a trial
• Study management and monitoring for Phase I-IV studies
• Third party vendor management
• Local sponsorship
• Full biometrics services, including randomisation and IWRS services
• Medical and CSR writing

In addition to the above, we are able to propose and manage fully vetted local vendors in areas in which we do not directly provide services ourselves. These include:

• Drug depot and logistics providers
• Central laboratories
• Translation service providers where required
• Phase I units
• Event managers (Investigators’ Meetings)
• Insurance brokers (indemnities)

Late Phase Research

In addition to the above, Novotech’s post-registration clinical trials services encompass the following:

• Phase IV clinical trials in specialist and GP settings
• Design and implementation of studies to address risk management considerations in newly marketed drugs
• Field research addressing health economics and pharmacoepidemiology questions relating to marketed drugs