“ We have been using DataFax since 1993 and really believe in this approach. With DataFax we are able to keep on top of all of our trials, reviewing CRFs from all sites immediately after each patient visit. ”

CROs offering DataFax

DataFax is in use at many contract research organizations around the world, some of which are highlighted on this page. We encourage you to contact these companies directly if you are interested in their services. Companies are listed alphabetically.

Applied Clinical Intelligence LLC www.a-ci.com

Applied Clinical Intelligence LLC

Applied Clinical Intelligence (ACI) is an industry leader in using DataFax for clinical trial data management and reporting. Our experience with DataFax is robust, having used it to efficiently complete dozens of studies of all sizes. ACI's senior DataFax staff have an average of over nine years of experience with this software, and our SOP-driven training of junior staff is reinforced on a daily basis by their expertise.

We bring the same innovation and quality to our DataFax projects that we ensure throughout out portfolio of services and products. ACI specializes in supporting safe and proper use of pharmaceutical, biotechnology and medical device products, and we're dedicated to applying the tools of the information age to the ever-changing environment of clinical research. Our team of seasoned clinical and regulatory professionals combines the advantages of extensive clinical development experience with a comprehensive understanding of real-world clinical medicine.

ACI's clients include global pharmaceutical companies, top biotech companies, and major CROs.

ACI's Scope of Services:

  • Data Management Services
  • Statistical Reporting & Analysis Services
  • Data Monitoring Committees
  • Specialized Clinical Consulting
  • Risk Management Products & Services

Clinical Data Care - Caring for Your Ideas www.clinicaldatacare.com

Clinical Data Care

Your clinical trial partner: Clinical Data Care is a focused, dedicated contract research organisation that works closely with you, enhancing your strengths and providing the additional expertise you need.

Expertise where you need it: Clinical Data Care is a leading Scandinavian contract research organisation with a strong, growing presence on the European market. With several international offices and an extensive network of partners, we have the resources to handle large-scale multinational trials.

Various Data Entry Solutions including DataFax: With years of experience from different data entry solutions, such as DataFax, remote data entry and electronic patient diaries, Clinical Data Care has the ability to guide you in the process of choosing the data entry solution best suited for your trial. In our experience, DataFax is one of the most rapid and efficient methods you can use, and we have numerous satisfied clients who can verify this. Our DataFax experience dates back to 1998, and the single largest DataFax study we have run included 85.000 pages.

Our people make the difference: The strongest argument for choosing Clinical Data Care is our highly motivated, expert staff. We place special emphasis on close collaboration with you, the client, to ensure that projects are carried out as efficiently as possible based on your organisation's situation and needs.

Fast delivery of reliable results: Whether your operation is a small start-up or a large multinational enterprise, Clinical Data Care is the only partner you need for your clinical study. Through efficient project coordination, we deliver reliable results in the shortest possible time. We are committed to preventive efforts to predict and avoid potential problems. You can expect the same high quality from everyone involved in a Clinical Data Care project. That's what we call caring for your ideas.

DF/net Consulting www.dfnetconsulting.com

DF/net Consulting

The data management professionals at DF/net Consulting can provide a variety of DataFax consulting and integration services for pharmaceutical, non-profit, and biotechnology clients.

Specializing in DataFax: DF/net Consulting is completely focused on offering services related to DataFax. Over the years, we have developed expertise on how to most efficiently use the product in all areas of data management: from DataFax installation and CRF design through study implementation and data entry. DF/net can leverage this expertise in DataFax to make efficient use of time and resources in order to keep projects on track.

International Experience: DF/net has extensive experience working in international settings. DF/net has provided infrastructure development of data management systems in a wide variety of technically challenging settings. This international experience is augmented through our involvement in worldwide HIV vaccine and prevention research.

DataFax Integration: DF/net's core skills are in the area of DataFax-specific integration, Case Report Form (CRF) design, and DataFax database setup. DF/net also provides DataFax software validation, DataFax edit check programming services, data entry, training, and other DataFax services. Since 1996, DF/net has successfully provided cost-effective DataFax integration, CRF development, database design, and other data management services for a variety of DataFax clients.

Encorium Group, Inc. www.encorium.com

Encorium Group, Inc.

Encorium is a leader in the design, development, and management of complex clinical trials for the world's leading pharmaceutical, biotechnology, and medical device companies. Encorium Group's intellectual, hard working approach makes us different than other Contract Research Organizations (CROs).

With a proven management and operations team that is built from the experience and expertise of world-renowned drug development leaders, we specialize in quickly and efficiently solving the scientific and operational challenges our clients face. Having completed studies in various countries in North America; Western, Eastern, and Central Europe; the Middle East, South Africa and Australia, Encorium Group is a truly global company with 4 of the world's 5 largest Pharmaceutical companies on our client roster. With some of the most recognized leaders in the industry on our staff, Encorium Group is known for finding the most cost effective, high quality ways to design and execute clinical studies.

We also have access to respected thought leaders through scientific advisory boards and other long-standing relationships in key therapeutic areas. Plus, we have strategic partnerships with important industry participants. Our streamlined operational model enables us to quickly adapt our teams to the ever-changing needs of Sponsors worldwide.

Encorium has therapeutic expertise in the areas of: Cardiovascular Diseases, Dermatology, Gastroenterology/Hepatology, Gene Therapy, Infectious Diseases, Medical Devices, Metabolic/Endocrinology, Neurology/Psychiatry, Oncology/Hematology, Respiratory/Allergy, Vaccines/Biologics, Women's Health

Factory www.factory-cro.com

Factory

Factory offers a complete range of services from study design to expert reporting in clinical evaluation of Medical Devices and Biologicals. Factory is successful because it combines medical and technical knowledge with quality controlled execution of clinical studies. An extensive network of contacts with interventional medical specialists in many different disciplines and with notifying bodies, throughout Europe, helps you to jump-start your clinical studies in Europe. We are very keen on the quality performance of our studies, for example we were the first CRO worldwide to hold an ISO 9001 quality certificate. Above this Factory can offer a one stop-shopping service, including pre-clinical testing, quality consultancy and regulatory advice; in short, all that is necessary for a successful and fast European market release of a Medical Device or Biological.

Factory's Data Management Service in particular focuses on:

  • DATA QUALITY

    In our opinion =SPEED= is the first requirement for quality data management. Feedback on data recorded as soon as possible is the main insurance for complete, consistent and plausible data. We aim to have the Investigator complete CRF data within a week after each subject's visit, and we respond to discrepancies within two weeks after the CRF has been received. We accomplish this through direct communication between Study Data Manager, Monitor, Investigator and Study Site Personnel assigned to sending study data to Factory.
    Factory uses DataFax for acquiring, tracking, and managing your completed CRFs. We use SAS to generate datasets ready for analysis and any required data listings.

  • & TRANSPARENCY

    As a service organisation we aim for the best solution to manage your data. We always start a study with a Data Management Plan to detail the Data Management team involved, any specific data processing needs and the weekly data flow schedule. The specific tasks for study set-up, conduct and closure are detailed in our Data Management Standard Operating Procedures. We have validation documentation on hand for our in-house DataFax system and SAS programs.
    Factory can provide you secure access to your database, with which you can view the completed CRFs and database data. In order to keep you informed we provide regular status overviews of study progress. Periodic newsletters, to keep the Investigators up to date, are also part of our standard services.

To discuss the best solution to manage your clinical study data, contact our Head Data Management; Pascal Groenen at T +31(0)30 2292727 or via p.groenen@factory-cro.com.

i3 Statprobe i3global.com/Businesses/i3Statprobe

i3 Statprobe

i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions. i3 Statprobe is the clinical data management division of i3, a global pharmaceutical services company that brings together the leading minds in specialized areas of expertise.

Our approach to integrated data services is shaped by superior industry experience, which spans international boundaries and ranges in scope from small Phase I studies to large-scale Phase IV and expanded access programs. This deep experience enables us to precisely pair technology and proven processes with the needs of your study. As a result, we can help you streamline the route to more comprehensive answers.

i3 Statprobe provides:

  • Comprehensive data management that spans CRF and database design from data capture and validation to database lock and freeze. Our combination of technology expertise and data experience enables us to adapt to new processes, anticipate data and process issues, and seamlessly support every aspect of a project.
  • EDC and integrated technologies that allow us to select the most effective application for each unique trial. i3 Statprobe uses a technology platform that is fully integrated -- from database build to eCTD-ready clinical study reports.
  • Biometric services including production of data listings, summary tables, statistical figures, and integrated safety databases, as well as protocol development, statistical design, programming, and reporting. We are recognized for our innovations in delivering biostatistical programming and analysis that is second to none.
  • Medical and scientific writing including clinical study reports, brochures, summary documents, and scientific presentations and manuscripts. Our access to technical and scientific experts throughout the i3 family allows us to fulfill whatever needs emerge for manuscript development, including medical, statistical, and data management expertise.
  • Functional alliances that give us the ability to draw on a set of unique tools and approaches to create a dedicated functional team tailored exclusively to your business goals.

For more information please visit our website i3global.com/Businesses/i3Statprobe or contact: Jeremy Edwards, Director, Business Development: jeremy.edwards@i3statprobe.com.

Premier Research www.premier-research.com

Premier Research

Premier Research is a leading solutions-driven CRO leveraging our commitment to therapeutic focus and scientific expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. Premier Research has provided support for more than 1,500 clinical projects since 1998. Our teams evaluate the unique needs of each client and provide solutions catered to their specific project requirements.

Premier Research is committed to providing the best mix of clinical research services. From protocol design and feasibility assessments through final study report, Premier Research excels in providing expert project teams for clinical trials. Using project management and reporting technology combined with expert data management and statistical analysis, Premier Research delivers consistent, quality results to help move your drug through the development process quickly and efficiently. We offer a comprehensive selection of services for every phase of your clinical development.

  • Clinical Trial Management
  • Medical and Safety Management
  • Data Management
  • Biostatistics
  • Medical Writing
  • Interactive Voice Response Systems
  • Regulatory Affairs
  • Quality Assurance
  • Dedicated Clinical Sites
  • Strategic Product Development

Premier Research has 29 offices and operates in more than 30 countries across Europe and North America. Our broad operational footprint allows many options for enrollment and enables access to diverse patient populations. Our geographic coverage also allows the use of local knowledge to understand how countries treat the disease under investigation. Our sponsors directly benefit from our regional employees and their detailed knowledge of the local clinical research environment and ability to communicate with investigators and regulatory bodies in their own language.

Premier Research is a leader in clinical research for Analgesia, Neuroscience, Oncology, and Infectious Disease and has a breadth of experience in medical device and pediatric clinical research. The development of new drugs and devices for the treatment of conditions in the above areas presents unique challenges requiring a depth of knowledge and experience throughout the project team and the organization that only a therapeutically focused CRO like Premier Research can offer.

Synteract www.synteract.com

Synteract

Established in 1995, Synteract is a privately held, full-service contract research organization (CRO), dedicated to meeting the various needs of biotechnology, biomedical, pharmaceutical, and drug industry firms. Based in Carlsbad, CA, with a branch office in Pennsylvania, the Company offers capabilities in protocol development, site management, clinical monitoring, data collection and management, biostatistics, medical writing, and safety surveillance.

To further assist you, we offer clinical staffing solutions in SAS Programming, MedDRA Coding and Training, Software Validation, and DataFax Database Development. To complement your existing DataFax resources, we recently begun offering a full range of services called DataFax Technical Resourcing.

Our services and experience with DataFax includes:

  • Customized validation documents to meet your specific requirements.
  • Our Applications group has designed over 100 DataFax studies.
  • We have experience importing legacy data and images from other clinical systems to DataFax.
  • Our experienced I.T. staff and Applications group can assist in any portion(s) of installation, validation, CRF design, study design, and DataFax training.
  • We will work with your staff at whatever level of involvement is desired.

Providing expertise in a wide range of therapeutic areas, the Company maintains a wealth of knowledge in oncology, ophthalmology, HIV, erectile dysfunction, cardiovascular disease, and pain. Since 2000, it has been a key development shop for web, wireless and voice data solutions that speed the completion of clinical trials and assist in access to clinical trials information. This would include such technologies as electronic data capture (EDC), interactive voice response systems (IVRS), and automated safety tracking and reporting.

For more information, please contact DFHelp@synteract.com or visit our website at www.synteract.com