CROS NT Creates Statistical Scientific Board

June 27, 2011 - PRLog -- The CROS NT Group has established the Statistical Scientific Board, a prestigious group of prominent statisticians who serve as a think tank for statistical methodology and offer consultancy on statistical challenges facing the clinical trial environment.

The goal of the Statistical Scientific Board is to combine the experience and knowledge of the Board members, all biostatisticians by background, in order to:
• Guarantee that clinical study designs and analyses approaches are industry-proven and authority-accepted.
• Guide, train and coach the CROS NT operational units for biostatistics and statistical
programming to ensure premium consultancy services.
• Verify that high quality standards of excellence for clinical trials reflect current and state of the art biostatistical methodology and Good Clinical Practice regulation compliance.

Consultancy is a pillar for CROS NT services, having built its foundation on analysis and
consultancy in biostatistics. With decades of experience on an international level, with both EMA and FDA, and a wealth of expertise, CROS NT created this Board to ensure the utmost quality in its statistical consultancy services.

The Statistical Scientific Board offers its expertise in the following clinical trial areas:
♦ Trial Design– Whether observational or interventional studies, the Board offers its expertise in complex trial design in all phases of clinical trials including randomized, blind and adaptive trial design.
♦ Conducting a Trial– While a clinical trial is being carried out, the Board provides support for data review when adaptive trials or DSMB is required. The Board is qualified and wellexperienced in attending to these trial needs.
♦ Filing and Reporting- The post-trial phase can also contain complications including proper case filing and analyses reporting. The Board has experience working with regulatory bodies and preparing reports based on industry standards.

How the Statistical Scientific Board Operates
The Board meets bi-annually to define training paths for consultancy and critical learning in statistics. Therefore, the Statistical Scientific Board works in conjunction with CROS Academy which is CROS NT’s educational and training program by supplying professional and quality training material. Consultancy from the Board members is allocated on a case by case basis depending on the expertise needed. Member expertise ranges from trial design, to safety regulations to geographic focus (EMA vs FDA), therefore the Board members can cover most, if not all, clinical trial statistical
consultancy requests.

Internal Board Members—CROS NT
- Riccardo Spezia (ITALY), Senior Statistician and Head of Medical Writing,
Chairman of the Statistical Scientific Board
Riccardo serves as Chairman of the Board, having worked in the Biostatistics field for over 25 years as a freelancer as well as inside International pharmaceutical companies
contributing to the development of drugs in different therapeutic areas. He has been a
trainer in statistics courses for non-statisticians since 1991.

- Paolo Morelli (ITALY), CEO of CROS NT Group, Professor at Bologna University
As the CEO of CROS NT Group, Paolo’s background is in Statistics and Programming. He has worked as a Statistician and Director of Biometrics in the pharmaceutical industry for over 10 years. During his career, he has participated in FDA hearings for clinical trials. Paolo also currently teaches 2nd degree level Biostatistics at the University of Bologna.

- Frank Freischläger (GERMANY), Vice President
Frank has held prestigious roles in Biostatistics including: Vice President of Global
Biostatistics & Programming at SIRO Group, Head of Biostatistics Europe for Omega
Mediation Clinical Research Services, Senior Contract Biostatistician for Merck Serono
International and Director of Biometrics Europe & India for Chiltern International.

- Thomas Zwingers (GERMANY), Chief Operating Officer
Thomas has previously worked for Estimate, a CRO specializing in statistical services. He has been working in clinical trials since 1980 in statistical analysis and written statistical reports. Thomas has contributed to over 70 publications and conducted CROS NT’s first webinar on Adaptive Trials. He has also presented studies to numerous regulatory authorities including BfArM, Swedish Regulatory Authority and EMA.

External Board Members
CROS NT has also contracted statisticians to add value to the overall level of expertise and cover a larger market both geographically and linguistically.

- Amanda Cross (UNITED STATES), Statistical Consultant
Amanda is an independent data services consultant based in Raleigh, North Carolina. She has spent 20 years in clinical trial statistics and data management, working with pharmaceutical companies and CROs. Amanda’s specialties are data collection and statistical reporting, refining procedures, document creation, proposal review and negotiation. She also has experience working with the FDA.

- Stephen Senn (UNITED KINGDOM), Statistical Consultant
Stephen has over 15 years statistical consultancy experience in the pharmaceutical industry in the UK, mainland Europe and the U.S. He spent 8 years as a Statistician and Group Head in the pharma industry in Switzerland followed by 8 years as a Pharmaceutical and Health Statistics Professor in England. He is a Chartered Statistician of the Royal Statistical Society. In 2001, he received the George C. Challis Award from the University of Florida for his contribution to biostatistics.

- Angela Montanari (ITALY) , Head of Faculty, Bologna University of Statistics
Angela has been Dean of the Faculty of Statistics and Chair of the study program in Statistics and Social Research at the University of Bologna. She is currently a Professor and Director of second level Master program in Biostatistics and on the teaching staff of the PhD program. Angela is also the Scientific Coordinator for CLADAG—Classification and Data Analysis Group of the Italian Statistical Society.

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CROS NT Group, an international Contract Research Organisation (CRO), with headquarters in Verona, Italy has built a strong heritage in biostatistics as well as providing clinical data management, medical communications, pharmacovigilance and technology solutions to the life science industry. Founded in 1992, CROS NT is well-established in delivering quality, timely, and cost effective service. The ARITHMOS branch of CROS NT provides IT solutions to the pharmaceutical and biotechnology industries such as hosting, data integration, computer system validation and software development to increase the success rate of clinical trials and drug safety development processes.