Advancing Trials. Improving Lives.

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

 

Unlocking Regulatory Complexities for Combination Products

The Key to Combination Product Success 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 … Read More

RFP Guide to Oncology Clinical Trials

This ebook is an RFP planning guide for small to mid-sized oncology sponsors Understanding the primary cost drivers for oncology clinical studies can be daunting. Novella Clinical developed this guide to help smaller oncology sponsors better understand the nuances of … Read More

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 Immuno-Oncology 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. Novella’s oncology teams have conducted more than 140 oncology … Read More

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

Methodology for Strategic Enrollment Projections Enrollment projections are critically important to biopharma companies with limited resources. The two primary drivers of realistic patient enrollment projections are data and experience. Novella Clinical utilizes both to develop strategic enrollment projections with a … Read More

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

Case Study: Study Start-Up and Enrollment

Novella Clinical’s rapid start-up and enrollment sets the course for successful execution of this Phase II prostate cancer drug trial Novella Clinical was approached by a clinical-stage biopharmaceutical company to run its Phase II prostate cancer drug trial in the US. … 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) Founded in 1998, Novella Clinical has more than 1,300 professionals supporting customers with individual attention and a collaborative approach. We specialize in the following areas: oncology, dermatology, medical device & diagnostics and … Read More

Oncology Overview

Helping You Improve the Lives of People With Cancer Novella Clinical is a global, full-service clinical research organization (CRO) serving small and mid-sized oncology sponsors as a trusted outsourcing partner since 1998. Having implemented more than 450 oncology trials to … Read More

Novella Clinical Quality Policy

We are committed to achieving your goals of positively influencing people’s lives. Our innovative and collaborative approach aligns to each person’s individual needs and is delivered with the honesty, attentiveness and passion on which our company was founded. Learn more … Read More

Oncology Hematology Overview

Dedicated Expertise in Your Fight Against Blood Cancers Novella has dedicated hematology / oncology teams and processes to support hematologic studies. Our specialists understand the clinical implications of blood-based cancers, the diverse pathologies, complex assessments, sick patient population, and lab-based endpoints inherent … Read More

Genitourinary Oncology Overview

Specialists Ready to Advance Your Next Genitourinary Trial. Genitourinary (GU) oncology is one of Novella’s largest areas of focus. More than 65% of our oncology trials have targeted solid tumor indications, including a number of rare cancers such as non-muscle … Read More

Medical Device Overview

As a specialty medical device CRO, we have gained a comprehensive understanding of the distinct needs and requirements of clinical device development programs. Our approach provides medtech companies both personalized regulatory consulting – critical early in the development phase – as … Read More

Clinical Resourcing Overview for Clients

Comprehensive Staffing Solutions Whether you need an entire project team or individual resources, we can assist you with short-term or long-term coverage. Our highly skilled team will work with you to develop resourcing solutions that meet your needs and objectives … Read More

Clinical Resourcing FSP Case Study

Novella Clinical Resourcing’s Functional Service Provider (FSP) Model Delivers Both Savings and Quality Novella Clinical Resourcing was selected by a leading pharmaceutical company to provide a team within the sponsor’s US clinical monitoring group in an FSP model. This partnership … Read More

Safety Management Overview

Comprehensive Safety Expertise Sets Us Apart Novella Clinical’s global Safety Management team supports oncology, medical device and dermatology companies across drug, vaccine and device studies (including drug/ device combination) using a purely electronic workflow. All safety files are digital, eliminating … Read More

Training Services Overview

Experienced eClinical training that understands “clinical” is the most important part Our Learning and Leadership Development team will help ensure your staff work smarter and your trial runs more efficiently. We’ve trained more than 17,000 clinical research professionals (from large … Read More

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

Novella Clinical’s core competency and therapeutic specialty is in cardiovascular device trials — comprising more than 50 percent of our medical device portfolio. Our specialized project teams consist of device-industry trained professionals with experience in sponsor, hospital and regulatory agency … Read More

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.