Clinical operations

Study start-up team 

Streamlined study setup 
Our expert study start-up team streamlines study initiation through advanced processes and strong global partnerships with clinic staff and investigators. We provide comprehensive regulatory support to help pharmaceutical and medical device organizations navigate the approval process efficiently. 
 
Comprehensive regulatory services 
Our end-to-end regulatory services cover the entire product lifecycle, including small molecules, biologics, biosimilars, vaccines, generics, advanced therapies, medical devices, diagnostics and over the counter (OTC) products. 
 
Key activities: 

• Study submissions to institutional bodies (eg CTIS/DMIDS) and ongoing notifications
• Tracking submission and approval statuses
• Managing study modifications with the medical writing team
• Preparing investigator site files (ISFs) with required documents
• Setting up and maintaining the trial master file (TMF). 

 

Project management

Expert project management with advanced technology 
By combining expert teams with advanced tools, we create efficiencies that exceed typical CRO expectations. Our project managers integrate seamlessly with your team, offering proactive guidance to achieve milestones faster while helping ensure robust financial control across studies. 
 
Financial focus and transparency 
We prioritise budget predictability and minimise change orders through responsible financial management. Our technology-driven costing models are adaptable, providing customised solutions for projects of any size or location. Transparency is at the core of our collaboration, from proposal to project completion. 
 
Our project managers: 

• Serve as the primary contact and communication hub for clients and teams 
• Lead the project team with clear expectations for timelines, quality and costs 
• Optimise global resources and processes for efficiency and accuracy 
• Establish a framework emphasising expertise, quality and task efficiency 
• Proactively manage risks and address challenges to project delivery 
• Maintain a flexible, innovative approach to problem solving

Medical writing

The ideal talent, expertise, and engagement models
Our medical writing team comprises highly qualified professionals (PharmD, MD, PhD and Master’s-level writers) with diverse therapeutic knowledge and extensive industry experience to meet all regulatory documentation needs.

Medical writing services
We provide a full range of regulatory documents, including clinical study protocols and reports, investigator brochures, patient information sheets and informed consent forms. We also review and enhance clinical evaluations, standard operating procedures (SOPs), and manuals, to help ensure all documents are accurate, compliant and delivered on time. 

Meeting your target audience's needs
Our skilled writers craft concise, clear and well-organised documents tailored to your requirements, adhering to the latest guidelines and standards. Every document is thoroughly proofread to ensure high quality, presenting complex information clearly for any audience.

Clinical monitoring

Nuvisan has a long-standing track record of successfully monitoring clinical trials. Our organisation offers monitoring of studies conducted in our Clinical Pharmacology Unit and for external clinical sites according to our SOPs, with trial-specific monitoring plans developed according to ICH GCP and all applicable regulatory requirements. Our unbiased and independent monitoring group covers complete or risk-based monitoring activities. 
 
Key activities: 

• Clinical monitoring plan development 
• Conducting site evaluation, site initiation, monitoring and close-out visits 
• Site training and communication 
• Site quality overview and appropriate issue escalation, if needed 
• CRF (case report form)/ECRF (electronic case report form): source data verification (SDV): 100% or with a risk-based models 
• Drug accountability check 
• Investigator site file (ISF) review