Advancing Trials. Improving Lives.
Learn how to make your trials more effective. White papers, overviews and fact sheets can be accessed here.
An examination of study design, considerations and endpoints Transcatheter aortic valve replacement (TAVR) changed the treatment of high-risk patients with severe aortic stenosis, while also raising concerns of complications, such as increased risk for stroke. The entry of embolic protection … Read More
Utilizing Investigational Technologies in Oncology Trials New technologies are changing oncology research – not only for cancer researchers but for patients. This paper explores the potential of liquid biopsies across diagnostics, therapy monitoring and disease recurrence from a clinical development … Read More
New Device Technologies Influence Treatment Options and Clinical Trials Choosing valve repair or replacement for most patients relies on the clinical judgement of their cardiologist and cardiac surgeon based on factors including overall health, the valve in question, and the … Read More
Understanding the Key Differences in the Clinical Trial Process Whether developing a new drug or medical device, designing and running clinical trials can be daunting. How drugs and devices are developed differ dramatically. Study design and regulatory pathways differ; requirements … Read More
Supporting Your Complex Immunotherapy Trials. Our experienced project teams and custom approach to serving biopharma companies enable us to support the complex nature of immunotherapy trials from first-in-human trials to registration.
Harnessing Gene-Editing Technology for Oncology Trials The gene-editing technology has captured the attention of the life science and investment communities not only as an elegant tool in the classical science sense — simple and precise — but also as efficient and easy … Read More
Enrollment projections are critically important to biopharma companies with limited resources. Learn more about our methodology behind strategic patient enrollment.
Small Biotechs Know They Have One Shot at Developing Immunotherapies The reality of leveraging a patient’s immune system to disrupt cancer through immunotherapy is compelling. Standards of care are shifting, and drug developers are eager to leverage new technologies. Smaller … Read More
Novella Clinical’s rapid start-up and enrollment sets the course for successful execution of this Phase II prostate cancer drug trial.
Novella Clinical delivers speedy database lock resulting in FDA approval three months ahead of schedule for a prostate cancer drug.
Novella’s creative approach speeds site initiation and database build in this Phase I, multi-center study.
Small Biotechs Know They Only Have One Shot at Developing Immunotherapies The reality of leveraging a patient’s immune system to disrupt cancer through immunotherapy is compelling. Standards of care are shifting, and drug developers are eager to leverage new technologies. … Read More
Seven Tips for More Effective Cardiovascular Device Trials The increasing cardiovascular patient population, regulatory and payer demand for improved and cost-efficient patient outcomes and evolving technologies are driving innovation, especially among small and mid-sized cardiovascular device companies. This paper examines critical … Read More
Investigating Candidate Treatments for Blood Cancers Today, conducting good clinical trials in hematological malignancies requires an understanding of a rapidly evolving treatment paradigm that is increasingly nuanced, complex and patient-directed. Sponsors developing hematological oncology therapies must capitalize on the principles … Read More
Explore Factors Most Critical to the Success of Late Phase Oncology Trials Many pharmaceutical, biotechnology and medical device companies have adopted globalization as a business model for their clinical trials. This model is especially pertinent within oncology with the number … Read More
Re-Imagine Oncology Data Management Clinical trial data technology (specifically electronic data capture, remote data review and advanced data visualization) combined with risk-based approaches to clinical monitoring presents sponsors, CROs and research sites with the opportunity to rethink traditional data management, … Read More
Driving Down Early Phase Oncology Protocol Amendments Oncology product development continues to dominate the global therapeutics market. This strength depends not only on continued use of existing products but also on the clinical and regulatory success of candidates now under … Read More
We are a full-service Clinical Research Organization (CRO). Novella has more than 1,200 professionals supporting customers with individual attention and a collaborative approach. We specialize in the following areas: oncology, dermatology, medical device/diagnostics and clinical resourcing.
Helping You Improve the Lives of People With Cancer. Our dedicated Oncology Division has the global experience, knowledgeable staff and robust infrastructure to support our customers from Phase I through approval. Learn more from this oncology overview about our early and late … Read More
Novella offers device-industry trained team members from clinical research and regulatory associates to data and project managers. Download a list of our core services and therapeutic experience here.
Our specialized project teams consist of device-industry trained professionals. We understand the unique nuances of orthopedic and neurological device development programs. Download this resource to understand why Novella has earned preferred vendor status with several of the world’s largest medical device companies.
Dedicated Expertise in Your Fight Against Blood Cancers. Novella has dedicated hematology / oncology teams and processes to support hematologic studies. Learn more about our experience conducting clinical trials in hematologic malignancies.
Specialists Ready to Advance Your Next Genitourinary Trial. Genitourinary (prostate, renal and bladder) oncology is one of Novella’s largest areas of focus. Learn more about our experience with active GU studies around the world.
As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of your program. Learn More.
Comprehensive Staffing Solutions. We recruit the right people and deliver them to the right place, at the right time – so you can deliver new drug therapies and devices to market.
Our Functional Service Provider (FSP) Model Delivers Both Savings and Quality. Download this case study to understand how we delivered significant cost savings to a global pharmaceutical company.
Comprehensive Safety Expertise Sets Us Apart. Our global Safety Management team supports oncology, medical device and biopharmaceutical companies across drug, vaccine and device studies (including drug/device combination) using a purely electronic workflow.
Our Learning and Leadership Development team can ensure your staff works smarter and your trial runs more efficiently.
Understanding Companion Diagnostics Development The need for personalized medicine has successfully brought together and fully integrated the previously separate activities of drug and in vitro diagnostic (IVD) device development. This white paper outlines the necessary considerations for companion diagnostic test … Read More
Effective Strategies in Identifying, Enrolling and Retaining Patients Patients are essential to the development and approval of new oncology therapies, but the accrual and retention of oncology clinical trial participants present nuanced and complicated challenges. This white paper moves beyond … Read More
Streamline Combination Product Development The shifting borders among traditional drugs, biologics and medical devices are poised to produce safer and more effective combination products that offer new diagnostic and treatment options for patients. But such novel combination products pose numerous … Read More
Understanding Premarket Device Development The global medical device industry is facing strengthening competition, rapid technological innovation and increasing regulatory scrutiny while growing at an impressive rate. This paper provides an overview of the current premarket device development arena and global … Read More
Four Key Strategies to Manage Interventional Cardio Device Trials While heart disease is the leading cause of death worldwide, thankfully significant advances in technology-based treatments for cardiovascular disease have been made in recent years. Sponsors seeking to bring implantable cardiovascular … Read More
The Roadmap to Outsourcing Medical Device Trials Consider this a roadmap for both large and small medical device companies looking to outsource clinical trials. Utilizing external resources can be attractive to device manufacturers due to both the financial and operational … Read More
With therapeutic and in-country expertise, we bring your clinical program global presence with local service.
Our specialized project teams include board-certified cardiologists as well as a network of cardiovascular-experienced CRAs. Download this resources for an overview of our cardiovascular trial experience, which includes sponsor, hospital and regulatory agency environments.
Strategies on 510(k) Premarket Reform The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued draft guidances to revise its 510(k) premarket notification process for medical devices. The revisions aim to bring efficiencies and … Read More
A global cardiovascular medical device company approached Novella Clinical to rescue a clinical trial active in nearly 20 countries. Novella Clinical’s rescue team resolves backlogs and gets study timelines back on track.