Covalent Group , Inc.

Industry:

Medical Testing & Clinical Laboratories

Description

Covalent Group specializes in the areas of clinical development that are scientifically and operationally challenging with respect to process, organization, data flow, statistical analysis, and complex therapeutics. Areas that include cardiovascular diseases, infectious diseases, oncology, gene therapy, gastroenterology, hematology, and cardiovascular surgery among others.

Clinical Program Development - We specialize in clinical trials with particular focus on the blend between conceptual issues of study design and operational excellence. By properly defining the parameters of a study at the outset, we can provide more timely, efficient, and accurate study completion, and avoid many common regulatory delays and rejections for prospective drugs.

Regulatory Affairs & Operations - New regulatory ground is being broken every day. To avoid delays and rejections, we have built a regulatory affairs team that is second to none. The team provides comprehensive regulatory strategy formulation, New Drug Applications (NDAs), and Biologic License Applications (BLAs), regulatory document preparation and review, and liaison services.

Project Management - Making sure every detail is addressed, our project management professionals provide a continuous source of communication to Sponsors and handle the day-to-day operations of every study we undertake. We do it with an eye on timeliness, regulatory approval, and customer service.

Site Selection and Management - Clinical research sites must meet strict criteria. Covalent Group has a team of experienced professionals dedicated to identifying and recruiting clinical trial sites that offer important strategic advantages for subject recruitment, investigator communication, and technology.

Subject Recruitment - Regarded by many as a main reason for bottlenecks in drug development, subject recruitment must be handled in a highly focused, strategic manner in order to get a new drug to market on time. Our expertise enables us to identify and address patient recruitment pitfalls in the study design phase, which leads to more rapid subject enrollment and quicker study completion.

Clinical Site Monitoring - Communication is the key to successful site monitoring. Our Clinical Research Associates create a thorough site monitoring plan for each study and carry it out with the latest methods and technology to ensure clear, accurate, global communication between teams.

Data Management Services - Covalent Group has automated the data management process by implementing a complementary suite of industry leading technology, including Oracle® ClinicalÔ, DataFaxÔ and the Covalent TeleTrial® system - our proprietary Interactive Voice Response (IVR) and Web-enabled technology system. This suite of technology assists us in the timely collection, validation, and reporting of clinical results to our Sponsors as well as regulatory agencies for Case Report Form review and tracking, database design, data entry, integrated clinical/statistical reports and manuscripts, subject enrollment, subject questionnaires, and supply management.

Biostatistics - With some of the world's leading biostatistics professionals working at Covalent Group, we are considered an important partner to many of the world's most recognizable bio-pharmaceutical companies. As such, we often assist Sponsors in their interactions with the Food and Drug Administration (FDA) and other regulatory agencies around the world. Our biostatistics team provides consulting, data analysis, and statistical reporting services throughout each phase of the drug development process.

Safety Surveillance - The safety of drugs and biologics is a major concern to all regulatory agencies as well as the general public. It is also our first priority in every clinical trial we conduct. Our safety surveillance group provides 24-hour coverage every day and medical oversight in support of our clinical trials.

Medical Writing - Comprised of Ph.D. and Masters-level individuals, the Covalent Group medical writing team produces clear, concise, scientifically accurate documents with format and content in strict accordance with prevailing regulations and guidance - whether territory-specific or global. Our team of experts creates protocols and amendments, final study documents, publications, safety reports, and regulatory filings.

Quality Assurance and Compliance - Covalent Group conducts field inspections, investigator audits, pre-submission protocol compliance audits, and GCP audits in compliance with FDA and International guidelines. Our highly qualified staff also provides training sessions and performs audits of study documents and clinical trial databases.

News Archive

Other News To Note. BIOWORLD Today; 11/3/2009 ...cells to a population level comparable to that reached using embryonic stem cells. The findings were published in the July 1, 2005, issue of Molecular Biology of the Cell. o Covalent Group, of Wayne, Pa., was awarded a multi-part clin ...more