Expertise to Move Your Potential. Forward.
The complexity of oncology trials require that the people who manage and monitor these programs have deep oncologic therapeutic and clinical research experience. Coupled with the OSI Pharmaceuticals and Prologue Research acquisitions, we have a growing team of 270+ oncology specialists to draw from to support your program.
Project Management
Strong project management leadership is an essential component of running a successful trial. Unique to oncology, a working knowledge of the disease and the clinical setting is needed to supplement strict project management skills. Our project managers have an average of 12 years of clinical research experience and have worked on oncology trials involving most types of solid tumors and hematologic malignancies. This gives us one of the most experienced PM teams in the industry.
As the primary point person, the PM is responsible for overseeing the Sponsor/CRO interactions, leading the cross-functional project team, monitoring performance metrics to assess project health, ensuring requisite training of staff, and that the services are delivered on time and on budget, with a high level of quality throughout.
Comprehensive project plans are prepared that specify goals and objectives, as well as to provide a road map to ensure clarity in communications, resources, training, key milestone timelines, and risk mitigation strategies. In addition, clients have 24/7 access to centralized real-time study information and data through ‘InfoLink’, our CTMS web portal and reporting system, which allows for full study transparency and proper Sponsor oversight.
In addition to assigning a PM with the experience and skills matched to your project, a member of senior management is assigned to each project to provide executive oversight and guidance.
Clinical Monitoring and Clinical Trial Management
Oncology clinical trials require experienced and educated teams to monitor the trials effectively and efficiently. Familiarity with source documentation at the site is perhaps the most essential aspect to assuring clean and timely data. All of our employee clinical research associates (CRAs) are experienced in the oncology therapeutic area. To be considered for the Oncology Business Unit, each is required to have a minimum of two years oncology monitoring experience.
In addition to our employee CRAs, through our resourcing division, Novella Clinical Resourcing, we have access to more than 1900 global oncology monitoring experts, ensuring that your study will be staffed with the expertise that is required. Because the role of the CRA is so critical to ensuring compliance, patient safety and data integrity, you will never see inexperienced or “green” CRAs assigned to your study from Novella.
All of our CRAs are generally managed by a Clinical Trial Manager (CTM) who is also required to have a strong oncology background. Our unique site management model has the CTM responsible for site management of the study, which ensures a knowledgeable person is always available to answer questions regarding patient eligibility and protocol compliance, while providing consistency of responses across all study centers. Our CTMs also mentor the team CRAs and help assure quality monitoring.
Regulatory Affairs
Novella offers strategic regulatory consulting for oncology products. We have regulatory staff with vast experience navigating through the clinical trial and product approval process with the FDA (USA), TPD (Canada) and EMEA (European Union). We can represent your company with various regulatory authorities, provide approval strategies, review technical documents and plans, and prepare GAP analyses. Our regulatory staff can submit initial applications to regulatory agencies and ethics committees, and maintain them throughout the lifecycle of the development program. Novella understands that local regulatory application requirements for clinical trials and applications are made in parallel with ethics committee submissions whenever possible. Additionally, we can assist with the procurement of import/export licenses.
Medical Monitoring and Safety
Novella provides medical monitoring by qualified physicians. Our Chief Scientific Officer (CSO) is a board certified hematologist/oncologist. His efforts are supplemented by 5 additional MDs with greater than 10 years of experience in oncology, as well as deep network of Key Opinion Leaders (KOLs) who specialize in the full spectrum of oncology indications. Our medical staff have the experience and know-how to support your oncology study from early planning and protocol design, to medical monitoring and SAE management, to regulatory submissions.
Data Management
Data Managers in the Oncology Business Unit are unique in that they have oncology therapeutic experience. They understand the complexities and intricacies of data collection and cleaning for oncology trials.
When it comes to data management solutions, Novella has the flexibility to leverage the best solution and platform for your study. Our Data Management solutions include:
- PhaseForward InForm™ (5.0) - fully integrated and in-house (i.e. eCRF design, programming, hosting)
- Medidata Rave™ – Accredited Plus standing
- Oracle Clinical ™ – internal double-data entry / paper-based system
- 3rd party vendors via an ASP model
Biostatistics
Oncology-focused statisticians, all with advanced degrees, are able to provide insightful study design and analysis plans, and to perform complicated data analyses for DSMC meetings, interim or ad hoc analyses, publications, and CSRs. Our biostatistical staff is adept at developing randomization schedules, adaptive designs, scientific consultations, interpretations of results, and accurate production of tables, listings and figures. Having statisticians experienced in oncology and involved from CRF design to final TLFs assures proper output to assess the effectiveness of your product.
Medical Writers
Our oncology-focused medical writers are able to prepare high quality investigator brochures, protocols, ICFs, CSRs, manuscripts, abstracts, and technical sections of regulatory applications. All writing conforms to ICH E3 guidelines and formatting for eCTD submissions can be accommodated.