Clinical Operations And Project Management

Services include project management through to clinical trial monitoring, management and patient recruitment. Novotech delivers unmatched experience as the Asia-Pacific’s leading CRO with 11 dedicated offices, expert teams and deep local regulatory knowledge.

Novotech is the Asia-Pacific’s leading clinical trial company. The streamlined and integrated clinical trial services are delivered by teams of professionals with strong industry and therapeutic area expertise across all phases of clinical development.
The teams also have established relationships with trial sites, key opinion leaders and Principal Investigators resulting in rapid and effective trial start-up,patient recruitment and site selectionto deliver on clinical timelines.

High customer satisfaction

Novotech has implemented a systematic mechanism of monitoring customer and investigator satisfaction across a range of items. We have invested in new technology and established clear processes to systematically reach out to our customers after key milestones for each project. This initiative is very important to us as we nurture relationships with our clients to address potential issues well in advance and ensure continuous improvement in our services. We have observed excellent levels of satisfaction in general and especially on items such as communication and project team quality.

A full range of Project Management services:

• Feasibility assessment and site selection
• Protocol development & CRF design
• Patient recruitment strategies
• Ethics Committee and Regulatory submissions
• Project management and monitoring for Phase I-IV trials
• Full biometrics services, including randomization and IWRS services
• Local sponsorship
• Third party vendor management
• Medical, technical and CSR writing

Site Management (SMO) activities

The highly experienced and qualified Novotech study coordinators and site management associates are key to the successful management of a clinical trial.

Novotech’s Site Management Organization (SMO) service provides highly qualified and experienced Study Coordinators (SCs) and Site Management Associates (SMAs) to help support both principal investigators and sponsors.

Through the SMO service, Novotech provides principal investigators with trained SCs to assist with daily clinical trial activity and patient recruitment; and sponsors with experienced SMAs to provide clinical trial site management and ethics committee support.