Monday, December 9, 2013
CROS NT is pleased to announce that it has received the CIR tax accreditation from the French government for a three-year period.
The French R&D tax accreditation, known as Crédit d'Impôt Recherche (CIR), allows French companies who are conducting research to claim corporate tax relief of up to 30% on costs associated with activities outsourced to CROS NT.
"The French market is an important one for CROS NT. We have obtained CIR tax accreditation as part of our aim to ensure our French customers receive optimum cost effectiveness and value for data management, statistics and pharmacovigilance services from CROS NT," says Global Head of Business Development and Marketing, Chris Hamilton.
For further information regarding the CIR tax accreditation, please contact us at firstname.lastname@example.org.
CROS NT est heureuse d'annoncer que le gouvernement français a accordé la certification d'accréditation d'impôt pour la recherche (CIR) pour une période de trois ans.
La certification d'accréditation CIR permet à votre entreprise de déduire 30% du crédit d'impôt pour les coûts engagés dans la Recherche et Développement avec CROS NT.
"Le marché français est importante pour CROS NT. Nous avons obtenu la certification d'accréditation CIR dans le cadre de notre objectif d'assurer à nos clients français efficacité maximale sur les coûts et la valeur pour les services de CROS NT y compris la gestion des données, la statistique et la pharmacovigilance," dit Chris Hamilton, Directeur de Business Development & Marketing-
Pour plus d'informations sur Crédit d'Impôt pour la Recherche (CIR), veuillez contacter CROS NT à l'adresse: email@example.com.
Friday, December 6, 2013
Clinical trial leaders are facing a new paradigm in the industry: rather than taking a strategy v. technology approach, leaders are now adopting a strategy AND technology approach in order to incorporate customized technology into their clinical trial strategy. This is particularly true for late phase studies which have become extremely relevant in the drug development process. Drug development companies are focusing on managing the full product life cycle rather than just gaining market approval. CROS NT discusses late phase studies and the implementation of customizable life science applications.
Identifying the Market Need:
Late phase studies are identified by rigid protocols and a shift from a small number of selected patients to a large number of normal patients. Most Life Sciences Commercial Off-the-Shelf (COTS) applications provide standard and common functionalities at comparable costs. Many COTS EDC systems address most requirements, but customization is often needed. Custom software can be developed to fit the company's business process and operational needs.
COTS can have drawbacks such as too many or not enough functionalities, high licensing and HelpDesk costs and low usability. Meanwhile, custom software applications can incur high development costs, bugs, high training and helpdesk costs, limited reuse of software code and the inability to use manuals and documentation for other projects.
To summarize, how can Sponsors in late phase studies account for changing needs while keeping drug development costs under control?
Identifying the Solution:
Customizable Life Science Applications are a middle ground between COTS and Custom Software. Benefits include:
- Paying for the functionalities needed and not paying for those not applicable to your study
- Ability to reuse the application with slight modifications
- Reuse of documentation
- Training effort kept to a minimum due to high usability
- Sponsor and site personnel use the same application for different projects
CROS NT's Customizable Software Solution
CROS NT acquired a baseline EDC software and developed it based on requirements written by Investigators. Symphony EDC has the basic functionalities such as data entry, source data verification, discrepancy management and eCRF approval. Other features include study design and build, smart logical security and documentation and reporting sections.
With the support of our sister company ARITHMOS, we have already created 5 customized versions of this software solution for 5 different Sponsors. In a particular late phase case study, the creation of a model application was to be cloned and customized according to customer requirements. A customized version can then be used for more than one study, and study setup and logical security can be easily managed.
About Symphony EDC
Symphony is a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data for late phase studies. The system can be aligned and customized to client requirements and is an ideal solution for studies which require a reliable, yet cost-effective solution. Classic EDC features include: electronic data collection, easy study database build, integration with ePRO, audit trail, query management and SAE management. To learn more, visit the Symphony website or join the Symphony System User Group on LinkedIn.
Monday, November 25, 2013
CROS NT Senior Biostatistican and Senior Director of Consultancy Services, Thomas Zwingers, prsesents an alternative solution to a multiple sclerosis study using multivariate analysis and the Wei-Lachin approach. Thomas presented this topic at an EMA workshop on multiplicity issues in clinical trials and the usefulness and limitations of newly developed strategies to deal with multiplicity.
To view the full presentation, please click below:
Thomas Zwingers is the Senior Director for Consultancy Services at CROS NT and a Senior Biostatistician. He has been working in the field of clinical trials for more than 30 years with particular expertise in statistical analysis and project management. He owned his own biometrics CRO in Germany before joining CROS NT in 2010. Thomas' areas of expertise include Adaptive Trial Design, interim analyses, meta-analysis and multiplicity. He has particular experience in the therapeutic areas of oncology and dermatology.
Thomas also leads CROS Academy - CROS NT's training branch which offers courses and webinars in the field of biostatistics. His courses include statistics for non-statisticians and adaptive trial design. Courses are designed and planned throughout the year, and on-site training courses can be arranged as well.
For more information or to inquire about statistical consultancy with Thomas Zwingers, please contact us at firstname.lastname@example.org.
Tuesday, November 19, 2013
As part of its life sciences technology portfolio, CROS NT offers EDC (electronic data capture) selections for Sponsors of clinical studies. CROS NT knows that one EDC system does not fit all studies, and therefore we offer a variety of solutions to meet any study or budget requirement.
There are many factors that influence this decision, including study phase, therapeutic area and indication, patient enrollment and, of course, budget. How should Sponsors make this important decision? CROS NT highlights a small checklist of criteria to evaluate.
Before any study gets underway, a budget is determined which includes costs for technology. Determine your budget for EDC systems, keeping in mind that there are EDC systems which allow for a pay-as-you-go option. It's no secret that pharmaceutical and biotech companies are looking to cut drug development costs, but this does not mean choosing the cheapest EDC system on the market.
Determining the EDC budget should be based on a cost-benefit analysis of the EDC system's functionalities versus the study's needs.
Now that you have an idea of your budget for an EDC system, analyze how intuitive the system is. Several factors can hinder the use of EDC, including concerns about it being too time consuming to implement, technical problems and lack of familiarity with EDC systems. Sponsors are going to want to choose a system with an intuitive interface and easy-to-use platform to minimize the risk of non-compliance by Investigators of patients or misuse during the study.
3. Operational Effectiveness
Evaluate EDC systems to make sure they have the features that are vital to the success of your study:
- Can you build your own study?
- Are there data entry, coding and randomization features?
- Are there Project Management tools?
- Are there customized reporting features?
- Are there re-usable templates and forms?
- Is the system compatible with GCP and/or regulatory guidelines? Is there an audit trail?
- Can the system handle multicentre, global studies?
4. Integration with ePRO
For collecting data electronically, Sponsors should consider the use of an ePRO device. Typically, a PC was used on site for all patients, but the market is shifting towards individual, handheld devices which patients can use from home. Internet connection allows data transfer as well as doctor-patient communication.
CROS NT has conducted studies using tablets such as the iPad and smartphones such as the Blackberry and Samsung Galaxy to collect patient data and capture the data in an EDC system.
5. Technical Support
Find out if the EDC vendors you are evaluating have technical support - including HelpDesk services and training. Training is essential for those who will be using the system to avoid error. HelpDesk should be available in order to resolve any technical issues immediately.
CROS NT understands that EDC system selection can vary based on study requirements and budget which is why we offer an assortment of EDC solutions in order to match the best solution for your study. CROS NT can provide ePRO and EDC integration solutions including licensing, installation, data storage and HelpDesk support. Below is an outline of our EDC systems:
Wednesday, November 13, 2013
CROS NT explains how choosing the right statistical method and supportive technology for your clinical study design will reduce timelines and lower costs while maintaining the quality and validity of a study.
In recent years, the pharmaceutical industry is witnessing a significant increase in costs for the development of new drugs. Companies site excessive study lengths and the high probability of failure as problematic areas for clinical studies.
Choosing the appropriate statistical method is crucial to success. The Bayesian Framework allows statisticians to increase their knowledge about a trial in a dynamic way as soon as new data or evidence is available. Thanks to the Bayesian method, prior information and new experimental data are combined to produce the so-called "posterior probability".
This approach can reduce timelines and overall costs in a variety of situations. For instance, it can help in the determination of the sample size, and the calculation can be more realistic and accurate using the prior information available at the start of the trial as well as what has emerged during the trial which increases the efficiency and reduces the cost of having an excess number of patients.
Bayesian models can be easily applied to Adaptive Designs, sharing the same idea of translating information into a decision as quick as possible. Therefore, studies doomed for failure can be terminated earlier to reduce the number of patients being treated with a non-effective drug.
Objectives normally requiring two separate studies can be achieved in a single trial by collecting information in the first stage which is immediately used in the second part of the trial. This has an obvious impact on the time to market, ultimately providing a quicker response to relevant medical needs. At each stage the probability of success can be quantified and the study team can be fully informed to evaluate the risks and benefits associated with each decision.
The Bayesian Model is even well suited for medical device trials. The FDA has encouraged the application of Bayesian methods as a way to cut costs in medical device trials emphasizing that "good prior information is often available" and "effects can sometimes be predictable from prior information on the previous generations of a device when modifications to the device are minor".
In order for statisticians to make these crucial "go/no-go" decisions, they need access to real time data. With modern technology such as smartphones and tablets, data can be collected from patients at multiple sites and sent directly to a validated EDC system for improved quality data and statisticians can immediately being making their estimates on adaptive measures like drug dose allocation, sample size calculation and possible termination. Technology solutions have even been developed to take into account adaptive designs and Bayesian models such as IVRS systems of trial supply management systems that can automatically adjust to design changes.
CROS NT has an expert team of biostatisticians with experience in applying the Bayesian Model to clinical trial designs. Our team has expertise in all phases of clinical trials and particular expertise in the therapeutic areas of oncology, respiratory, cardiovascular, dermatology and medical device trials. CROS NT offers statistical consultancy for trial design, methodology and regulatory submissions. Our training branch, CROS Academy, offers courses and on-site trainings (upon request) on biostatistics topics including adaptive trial design.
Tuesday, November 5, 2013
CROS NT has been working with its technology partner, Arithmos, to invest in technology developments to meet the needs of the pharmacovigilance market, particularly the need to make data more readily available. One solution is the integration of Oracle AERS and Oracle Business Intelligence to meet a specific need: providing a user-friendly platform that allows real-time access to structured data.
The Oracle AERS and Business Intelligence integration is an investment in outsourced pharmacovigilance work which requires the need to access real time data and results. The current process involves an Oracle9i database and periodical reporting through SAS which publishes reports in a web page. However, the data is not always available in real time, therefore we have identified the following user requirements:
- Accessibility to live data anytime, anywhere in accordance with regulatory requirements
- Aggregated data: the ability to navigate, modify and interact with results
- A flexible platform and an easy-to-use interface
The proposed solution is an integration of the Oracle9i database with Oracle Business Intelligence Standard One edition which creates an Oracle interactive dashboard that allows companies to constantly access data and results. The implementation process requires building a Business Intelligence repository, analyzing data and publishing data on the Dashboard. An ODBC connection is required to import Oracle AERS data into an Oracle BI repository where there are 3 layers: Presentation Object, Logical Business Model and Physical Data Sources.
The Oracle BI Dashboard Management allows customization of page layout according to user requirements. The Dashboard is interactive, which allows companies to access live data corresponding to user requirements.
Why Invest in Pharmacovigilance Solutions?
The pharmacovigilance market is expected to grow to $2.2 billion USD by 2015, according to a Frost & Sullivan report. The FDA and EMA have increased regulations on drug safety, and in an effort to cut costs, pharmaceutical companies are outsourcing drug safety work. A burdening cost for most companies is technology and the migration of data from one system to another. The pharmacovigilance market will benefit from system integration that provides readily available data and results.
CROS NT is attending Pharmacovigilance Day, hosted by Arithmos and Oracle, on Tuesday 12th of November in Milan. This seminar addresses the challenges of pharmacovigilance - including new regulations and reporting options. The event features experts on pharmacovigilance systems and data migration solutions. While the event is free of charge for participants, spaces are limited. Registration is still open!
Thursday, October 31, 2013
As technology plays a bigger role in clinical trials, study managers are looking for readily available data that is easy to extract. Business Intelligence is the use of computer-based techniques to collect and analyze data. CROS NT outlines a clinical data visualization solution that puts trial analytics right on your smartphone or tablet.
Through our strategic partnership with ARITHMOS, who is an Oracle Gold Partner, CROS NT is a user of Oracle Business Intelligence. Its team of Oracle application experts was looking for a way to integrate Oracle BI with new market technologies - in particularly smartphones and tablets. Here is a solution for Oracle BI on the iPhone and iPad.
The rationale was that the iPad and iPhone are ideal devices for access to study data and information because:
- They are easy to use due to small size and zero footprint installation
- Accessible anytime due to Internet availability
- Able to focus on useful data
Prior to Oracle BI 22.214.171.124 there were many ways to access study data including standard reports, web portal for downloading data, Excel files sent via email and sFTP reporting. These methods are not portable and do not always have Internet connection availability.
Oracle BI provides the BI publisher "app" for iPhone and iPad which is available for download in the Apple iTunes store. The system requires first the installation of an Oracle database and the BI system. Then, BI should be installed with the Publisher component. The installation of Oracle BI Mobile to the iPhone is a straightforward configuration of the connection to the BI Publisher Server. Communication is secure using HTTPS, and then credentials are created for the user. The same process can be applied to the iPad.
Once logged in, data can be accessed via the Catalog where personal and shared folders are available. The iPod and iPad application also make specific reports available including enrollment status, SAE reporting, study metrics, site personnel and monitor activities, and aggregated study data. The devices are in fact easily portable and have easy access to WIFI of Internet subscriptions.
Why Consider Clinical Data Visualization "on the go"?
This technology allows reports to be run across different databases from different systems. Perhaps this is the biggest benefit to data visualization tools - being able to analyze clinical metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise at a particular site or with a particular patient, when adverse events are entered or when a resupply is needed. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial "go/no-go" decisions on study progress.
CROS NT has created a web portal, called CROS Check, to provide information and resources on clinical data visualization.