Published on February 19, 2014
CROS NT Company Presentation www.crosnt.com
Company Overview – PM Holding CRO Business, niche services in ST, DM, PhV, MW Dedicated to recruitment and insourcing for Pharma Dedicated company to satisfy IT needs in Pharma
Company Overview – CROS NT Celebrating 21 years in business this year Offices in UK, Italy, Germany; Consultants in the U.S. ISO certified Over 800 projects completed Customers from pharma, biotech, medical device and academic sectors Strategically partner with CROs based on clinical, geographic or therapeutic area needs Strategic partnership with Arithmos to provide life science technology solutions
Company Overview – About Us Centre of Excellence for Clinical Trial Data: CROS NT has remained specialised in biometrics as more and more Sponsors are seeing the value in centralized data. CROS NT also provides a Functional Service Provider (FSP) strategic outsourcing model which streamlines operations, accelerates timelines and cuts costs. What we provide:
Company Overview - Why CROS NT? Dedicated to clinical data services (centre of excellence) with accompanying technologies Services covering Protocol to CSR Top talent and experience in providing statistical advice (FDA and EMA, DSMBs, Adaptive Design etc.) Processes and technology that ensure excellent planning, management reporting and traceability of projects Focus on standardization and minimization of costs Overall achievement is higher quality at a lower price 100% customer retention Less than 5% staff turnover Obtaining ISO 22301- the world’s first international standard for Business Continuity Management
Therapeutic Area Expertise
Therapeutic Area Expertise CROS NT has completed over 800 clinical studies in a variety of therapeutic areas, providing statistical analysis and programming and data management services. In addition to these therapeutic areas, we also have experience in immunology, neurology, vaccines, CNS, ophthamology, gynaecology, metabolic diseases, rheumatology and haematology.
Therapeutic Area Expertise – Respiratory Respiratory is a therapeutic area of expertise for CROS NT, given that we have completed approximately 100 studies in this area, on both single country and international level and in various clinical phases and post-market studies.
Therapeutic Area Expertise – Cardiovascular/Cardiology We have conducted approximately 70 cardiology studies for some of the world’s largest pharmaceutical companies. CROS NT has performed data management, statistical analysis and programming for cardiovascular studies in Phases I-IV as well as observational studies. In a recent study for a large pharma company, CROS NT provided a biometrics package of DM, STAT, PhV, and statistical consultancy support for the DSMB for a Phase II hypertension study run in 24 sites internationally.
Therapeutic Area Expertise – Oncology CROS NT has completed more than 70 clinical trials in multiple oncology indications from small Phase I trials to large Phase III-IV multinational trials. We have worked in a variety of indications including breast cancer, colorectal cancer, AML, lung cancer, lymphoma and leukemia. Recent Examples Study 1: 1,200 patients in 104 centres Study 2: 3,754 patients in 135 centres Study 3: 793 patients in 104 centres Study 4: 3,642 patients in 138 centres CROS NT is currently involved in 10 on-going oncology studies with 8 different Sponsors. CROS NT has been working since 2009 on a breast cancer study for a large pharma company. It is a randomized, multi-centre study involving 4,173 randomized patients. We are also attending DMC meetings as independent statisticians.
Outline of Services
Strategic Outsourcing Approach: Centralization of Data • Centralizing clinical data falls under the functional service provider outsourcing strategy. It has the potential to increase quality while reducing overall costs. Problems Sponsors Face When Data Is Not Centralized Solution: Benefits of Centralized Data Lack of traceability of information Less risk Difficult cross product analysis, unexplained conclusions when numerous companies handle data All data in one place: greater efficiency, consistent communication and reporting using common assessment methods Slow resolution of regulatory queries Improved response to regulatory obligations Unfamiliar with Sponsor requirements Increased Value of Intellectual Property Dispersed clinical data across a programme of studies Reduced Costs
Strategic Outsourcing: Functional Service Provider Model • • • FSP: outsourcing model whereby CROS NT provides a scalable team of resources working from CROS NT offices with occasional site work Billing done monthly based on hours worked (rather than fixed pricing) Benefits: – – – – – – – Scalable team of experts in DM, Biostatistics, PhV, Medical Writing Continuity of trained resources Improved and accelerated timelines Control of overhead costs Consistent pricing Reduction in Sponsor Project Management time Lower recruitment/HR costs 13
Life Sciences Technology Portfolio Symphony is a simple, low cost, web-based Electronic Data Capture (EDC) system for collecting, managing and reporting data from clinical trials. 14
Clinical Data Management CROS NT has acquired extensive knowledge through the management of vast amounts of data generated by clinical trials. This enables the DM team to improve speed, efficiency and cost effectiveness while conducting clinical trials. An expert Data Management team can provide: CRF Design & Review DB Design Data Management Report Development Development and Programming of Data Validation Specifications Data Management Plan Development External Data Providers Management CRF Tracking Data Entry Fax-Scanner Data Entry Medical Coding Instream Data Review Discrepancy/Query Management Database Quality Control EDC Insourcing of Data Managers at Sponsor Site CDISC SDTM Compliant Databases 15
Biostatistics CROS NT has delivered expert statistical analyses across all phases of drug development and in a wide range of therapeutic areas for over 20 years. Each analysis is conducted using validated and standardized procedures in compliance with regulatory guidelines. Our expert statistical methodology team can provide: Blind Review: Planning, Meeting & Documentation Randomization Management Study Design Protocol Writing & Review Sample Size Calculation Statistical Analysis Plan Data Review Filing and Reporting for Regulatory Submission Statistical Consultancy Integrated Summaries of Safety and Efficacy Adaptive Trial Design + Bayesian Method 16
Statistical Programming CROS NT maintains a highly qualified group of SAS programmers to provide excellent statistical analysis and reporting. We require 6 months of prior programming experience to become a CROS NT SAS programmer and a minimum of 2 years of experience to be a Senior SAS programmer. Our expert team of statistical programmers can provide: Meta-analysis Data Listing Statistical Reporting Presentation of Results ISS/ISE pooled dataset creations CDISC Consultancy Legacy data conversion to SDTM/ADaM Creation of SDTM/ADaM for ongoing studies SDTM/ADaM Modelling Consultancy 17
CDISC Consultancy CROS NT statisticians have training in CDISC standards and implementing SDTM and ADaM datasets. The statistical programming team can prepare ADaM datasets for both traceability and analysis-ready requirements. CDISC related services include: Taking customer defined standards and creating CDISC SDTM and ADaM datasets Creation of documentation related to SDTM: SDTM annotated CRF, SDTM metadata, DEFINE.PDF, DEFINE.XML Creation of documentation related to ADaM: Analysis level, dataset level, variable level, parameter level documentation Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and FDA submission Creation of documentation for integrated databases Statistical programming for TFLs using ADaM derived datasets as input for the production of statistical results 18
Pharmacovigilance CROS NT offers a case data entry, processing and reporting service for adverse events via a hosted safety database. It can also provide the installation & validation of Oracle AERS or Argus safety databases on customers’ servers. Our expert pharmacovigilance team can provide: Low cost Case Data Entry Periodic Reporting Adverse Event Processing Expedited Reporting Safety Narratives Set-up & Management of a Global Safety Database EudraVigilance registration & reporting Risk Management Plans 19
Medical Writing CROS NT has compiled an expert team of Medical Writers with decades of experience in both Europe and North America. Our expert Medical Writing team can provide: Clinical Study Reports Common Technical Documents (CTD/eCTDs) EMA and FDA Briefing Packages Investigator Brochure Statistical Analysis Plans (SAPs) Integrated Summaries (ISS/ISE) PSUR/DSUR Posters Abstracts 20
Statistical Consultancy CROS NT has conducted over 500 studies that including statistical analysis and consultancy. In 2012, CROS NT created an independent consultancy department and named a Director of Consultancy Services to offer exclusive statistical consultancy services to pharmaceutical companies, including: Complex Trial Design: Adaptive, Randomized, Blind Bayesian Framework Interim analyses DSMB Support ISS/ISE Regulatory Submissions (FDA and EMA) CDISC Standard Implementation Training Courses & Webinars 21
Statistical Consultancy – Adaptive Trial Design • Adaptive Trial Designs offer greater flexibility and the possibility to modify a study in progress such as: sample size, criteria for inclusion/exclusion, changes in doses or treatment regiment, study endpoints, and the possibility of early closure • CROS NT’s expert statisticians can assist with following: Work with sponors to improve the trial design Use simulations to calculate the power of the sample size and the probability of success Define the decision rule for interim analyses and provide statistical justification Provide EDC and reporting to efficiently manage data for interim analyses 22
CROS Academy Building off CROS NT's strong statistical heritage and expertise, CROS NT created CROS Academy which provides a series of webinars and on-site courses from top statisticians within the CROS NT organization as well as external consultants. Courses Planned for 2013: Introduction to Adaptive Trial Design (June 2013 in Italy, Germany, UK) Statistics Workshop (June 2013 in Switzerland) Biostatistics for Non-Statisticians: Understanding the Statistical Elements of a Study Protocol (September 2013) How to Read a Trial Publication (November 2013) 23
CROS CHECK – Web Portal for Data Visualization We offer a clinical data intelligence solution which includes a clinical research analytics tool – customizable to your reporting needs and functional with any system – to provide the most detailed reporting of structured and underlying data. 24
www.crosnt.com firstname.lastname@example.org @CROS_NT CROS NT Clinical Corner 25