Experience
Oncology Experience
- Experienced oncology medical staff
- Experienced clinical and regulatory staff with proven oncology track records
- Oncology knowledge across all functional areas (data, stats, safety, etc.)
International Footprint
- Offices in the UK and Russia with 150+ staff in every country across Western, Central and Eastern Europe.
- A Network of International partners and affiliates for implementation in pan-Asia and South America
- Local, native-speaking monitors and regulatory experts for each country's specifics
- Access to 2,500+ oncology experienced CRAs in North America and Europe to identify the right fit of indication knowledge, location, and site relationships
- Active, global oncology trials in over 20 countries; proven support of approved compounds
Why choose Novella's Oncology Business Unit?
- Exclusively focused on oncology clinical trials
- Extensive clinical and industry experience
- Shared commitment to program success
- Timely, accurate, and open communications
- Tools to significantly improve protocol compliance
- Strong investigator relationships – Highest ranking CRO in sponsor surveys
- Consistency – greater than 90% project team retention
Data Management, Biostatistics, Safety, and Medical Writing
- EDC studies: fully in-house PhaseForward InForm platform, highest accredidation with Medidata Rave, or ASP model with 3rd parties like BioClinica and DSG
- CTMS: internally-developed and linked with EDC for study transparency (InfoLink2)
- Pharmacovigilance: Argus 7.0 safety system
- Proprietary prospective advice rules which improve investigator compliance
- Automated data collection methods resulting in timely database updates
- Accurate interim reports and analyses
- 24x7 Sponsor access to current data through secure Web-based extranet
- Sample size calculations
- Statistical consulting
- Statistical programming, analysis, and reporting
- Medical writing for regulatory submissions (protocol development through NDA)
and journal publication
Investigator Relationships
- Wide network of well-known oncology physician investigators (>7,600)
- Successful execution of oncology trials at over 700 sites, treating more than 35,000 patients
- Experienced management and staff with previous success with FDA oncology drug approvals
- Coordination of investigator activities, including patient recruiting and screening
- Site selection and oversight services that monitor patient registration processes and affirmation of compliance throughout the trial
Experienced Management
In-depth Oncology Expertise
Proactive Communication
Timely and Accurate Information
Easy Access to Data
Expert Data Analysis and Summarization
This is what sets Novella Oncology apart from the rest. We can help advance any drug, biologic, or medical device within your clinical development program to the next level and through to approval.
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