Advancing Trials. Improving Lives.

Learn how to make your trials more effective. White papers, overviews and fact sheets can be accessed here.

 

Biologics: The Key to Next Generation Dermatology R&D?

The evolution of biologics within the dermatology landscape Biologics present new treatment options for dermatology patients who haven’t seen positive results from traditional treatment methods, such as topicals, phototherapy or traditional drugs. This paper explores the evolution of biologics within … Read More

Dermatology Division Brochure

You require a CRO partner with dedicated experts and global site relationships. Our dermatology division is led by a team of specialists with 20+ years of experience and global in-house expertise spanning dermatology products and aesthetics. Download our brochure to … Read More

Dermatology Patient Recruitment Management Overview

The difference between successful clinical trial enrollment and missed deadlines is comprehensive patient recruitment management planning. With more than a decade of patient recruitment experience and strong site relationships, Novella Clinical’s Dermatology Division provides innovative and cost-effective solutions to enhance patient … Read More

Global Dermatology Regulatory Services Overview

Designing effective and efficient clinical trials often lies in effective regulatory strategies. Novella Clinical’s Dermatology Division is ready to put our experience to work for you. From our years of interacting with the Food and Drug Administration (FDA), European Medicines … Read More

Dermatology Data Management Services Overview

The integrity of clinical data is paramount to the successful reporting of clinical trial results. Novella Clinical’s Dermatology Division employs leading technologies that provide access to clinical trial data as well as status information throughout the trial. Our data management … Read More

Case Study: Acne Vulgaris Canada Early Phase

After a delayed last patient in (LPI) date, Novella Clinical reviewed the tactics and helped devise and execute a campaign that helped sites complete enrollment for a Phase I and IIa acne vulgaris study in Canada.

Case Study: Actinic Keratosis Phase III

Failure of sites to fulfill enrollment expectations on time often leads to major delays in clinical development programs. Novella Clinical was selected to conduct multiple large Phase III actinic keratosis studies, which involved from 60-960- patients in various sites in … Read More

Case Study: Atopic Dermatitis Global Phase II

When a global Phase II atopic dermatitis study faced numerous challenges, including language, cultural and time difference, ans well as seasonal fluctuations in disease prevalence, Novella Clinical was selected to provide recruitment/enrollment management, vendor management, a risk-based monitoring approach, system … Read More

Case Study: Atopic Dermatitis US Phase II

Failure of sites to complete enrollment on time is a major cause of delays in clinical development programs. Relying on its expertise in dermatology, a leading pharmaceutical company engaged Novella Clinical’s patient recruitment team to assist with curtailing an enrollment … Read More

Case Study: Common Warts US Phase II

A 12-week study startup goal had been established by the sponsor of a Phase II multicenter efficacy and safety study on common warts, so sites were activated on a rolling basis to meet the first patient in (FPI) milestone. Working … Read More

Case Study: External Genital Warts Phase III

A leading pharmaceutical company with a focus on men and women’s health selected Novella Clinical’s Dermatology Division to provide patient recruitment services for a Phase III external genital warts study. The sponsor selected Novella because of its reputation as a … Read More

Case Study: Hyperhidrosis Global Phase III

Novella Clinical was asked to conduct a Phase III safety and efficacy study of a treatment for hyperhidrosis (excessive sweating) at sites in the US and Germany. The study required a large patient population in order to meet all the … Read More

Case Study: International Phase III Psoriasis

A leading global pharmaceutical company selected Novella Clinical to support four large, international Phase III biologic studies in moderate to severe psoriasis. Novella’s Dermatology Division was selected because of its proven patient recruitment process with a record of enrollment that … Read More

Case Study: Onychomycosis Phase II

A leading pharmaceutical company specializing in dermatology approached Novella Clinical to conduct a large Phase II onychomycosis study involving approximately 440 to 460 patients across 25 US and Canadian sites. Novella’s Dermatology Division was selected because of its reputation as … Read More

Case Study: Phase II Psoriasis Summer Enrollment

A leading global pharmaceutical company with a focus on dermatology selected Novella Clinical to conduct two large, Phase II psoriasis studies involving a combined 700 patients at 40 sites. Novella was challenged to achieve the sponsor’s goal of randomizing 300 … Read More

Case Study: Phase III Psoriasis

A leading global pharmaceutical company with a focus on dermatology selected Novella Clinical’s Dermatology Division to conduct a large Phase III psoriasis study involving over 1,100 patients at 60 sites. Novella was challenged to achieve the sponsor’s goal of randomizing … Read More

The Promise of Liquid Biopsy Technology

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

Innovations in Heart Valve Technology

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

Clinical Study Requirements: Drugs vs. Devices

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

Immuno-Oncology Overview

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.

CRISPR-Cas9: Catalyst for Oncology Clinical Trials?

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

Patient Enrollment Overview

Enrollment projections are critically important to biopharma companies with limited resources. Learn more about our methodology behind strategic patient enrollment.

Mastering Oncology Immunotherapy Clinical Trials

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

Success Criteria for Small Cardiovascular Medical Device Sponsors

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

The Nuances of Hematological Oncology Clinical Trials

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

Planning for Success: Global Oncology Trials

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

Oncology Data Review

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

Optimizing Early Phase Oncology Clinical Trials

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

Corporate Fact Sheet

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.  

Oncology Overview

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 Clinical Quality Policy

Learn more about Novella Clinical’s innovative and collaborative approach to quality by downloading our policy document.

Oncology Hematology Overview

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.

Genitourinary Oncology Overview

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.

Oncology Case Study

Novella Clinical’s rapid start-up and enrollment sets course for successful oncology trial execution. Learn more by downloading the case study.

Medical Device Overview

As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of your program. Learn More.

Clinical Resourcing Overview for Clients

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.  

Clinical Resourcing FSP Case Study

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.  

Safety Management Overview

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.  

Training Services Overview

Our Learning and Leadership Development team can ensure your staff works smarter and your trial runs more efficiently.  

Clarifying the Regulatory Road for Combination Products

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

Best Practices in Outsourcing Medical Device Clinical Trials

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

Medical Device Cardiovascular Overview

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.

Medical Device Orthopedic Overview

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.