ARITHMOS Announces Pharmacovigilance Day 2013

ARITHMOS, with the support of Oracle, is hosting the first annual Pharmacovigilance Day this autumn to address the challenges of pharmacovigilance for pharmaceutical, biotech and medical device companies as well as CROs. This event is a workshop on modern pharmacovigilance technology solutions concerning both European Union regulations and improving operational efficiency for pharmacovigilance management processes.

The workshop is taking place on Tuesday, 12th of November in Milan, Italy. This event is free of charge but limited seats are available, and the expert panel will present in both Italian and English. 

Milano

Why a focus on Pharmacovigilance?

drug-question-mark

The European Union and the European Medicines Agency (EMA) have taken steps to improve patient safety in clinical trials based on the startling fact that 200,000 patients die each year from Adverse Drug Reactions. Companies are faced with the challenge of finding solutions that can improve the quality and analysis of safety data while managing the increase in quality of data and the need to satisfy regulatory requirements.

The latest pharmacovigilance regulations – known as Good Pharmacovigilance Practice (GVP) – went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports (ICSRs). Due to the increased regulation on safety data and the need to improve data quality, pharmacovigilance becomes very data intensive and difficult to manage.

The workshop features a panel of experts who will discuss the implementation of technology solutions for meeting the following challenges:

  • Pharmacovigilance Regulations
  • Pharmacovigilance Databases
  • Cloud-based solutions for Pharmacovigilance
  • Safety Data Migration
  • Regulatory and Customized Reporting
  • Signal Detection

Workshop speakers include experts on pharmacovigilance systems including Robbert van Manen of Oracle, Mike Roberts, an Argus Safety expert from Pink Octopus Consulting, Marco Bulleri of Abiogen and Gianluigi Albertini and Stefano Piccoli of ARITHMOS who will do a joint presentation on leveraging cloud technology in pharmacovigilance and the challenges of compliance.

To read presentation abstracts and the biographies of the presenters, visit the Pharmacovigilance Day website:

In English
In Italian

For more information on the event including registration, follow the links below:

In English
In Italian

Advertisements

Late-Phase Trial Strategy & Technology

edc1Clinical trial leaders are facing a new paradigm in the industry: rather than taking a strategy vs technology approach, leaders are now adopting a strategy and technology approach in order to incorporate customized technology into their clinical trial strategy. This is in particularly true for late-phase studies which has become extremely relevant in the drug development process. Pharma companies are focusing on managing the full product life cycle rather than just gaining market approval. Arithmos discusses technology strategies for late phase studies.

Identifying the 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 company’s business processes and operational needs starting with an established and tested software basic version.

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.

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

Example of Customizable Software Solution in Use

Arithmos developed a baseline EDC software based on requirements written by investigators. The basic functionalities such as data entry, source data verification, discrepancy management, eCRF approval have been implemented. Other features include study design and build, smart logical security and documentation and reporting sections. From this baseline, Arithmos has created 5 customized versions of the software for 5 different sponsors. In this particular case, 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. Documentation can be centrally managed on a study/user level, and reports can be customized study by study.

sym

Arithmos has developed 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 ideal for studies which require a reliable, but 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 about this software join the LinkedIn System User Group or visit Arithmos at an ePharma Day event this fall for a full explanation of the case study.

ArithmosCentrum and the Challenges of the 21st Century Human Resources Manager

HRThe role of the Human Resources Manager has changed drastically over the last decade. While Human Resources was once associated only with the hiring of employees, the Human Resource department today has an overwhelming amount of responsibilities and tasks within an organization. He or she can be responsible for knowing and implementing new laws, maintaining proper documentation, hiring and firing employees, managing relationships between colleagues and resolving disputes as well as managing the company’s resources for upcoming projects.

Arithmos discusses the challenges of a 21st century Human Resources Manager and how ArithmosCentrum integrated software can help.

1. Document and Knowledge Storage

Human Resource Managers are responsible for knowing current labor and business laws in order to make sure the company is complying with all of its legal obligations.

ArithmosCentrum supplies the Human Resources department with document storage for all important Human Resources documents. AC’s administrative settings allow access only to those granted, therefore the Human Resources Manager can ensure documents are not accessible to the whole company.

2. Employee and Candidate Records

The Human Resources department’s main responsibility is to manage employees and employee relationships. During the hiring process, the HR Manager needs a place to store candidate CVs/resumes, job descriptions and interview questions that are available with just a click.

Once employees are hired, the Human Resources department needs to keep track of all of their records including qualification forms, official documents like copies of ID cards, CV/resumes, biographies and training records.

ArithmosCentrum can help HR Managers, especially those with small to mid-size companies, organize all of this information in one integrated system. This becomes particularly useful when Project Managers are putting together a project team and need to pull biographies and qualification forms. It also helps Line Managers follow employee training plans, and HR Managers can know if employees are complying with local law regarding required training. ArithmosCentrum has a module that allows all training logs to be displayed and printed.

3. Managing Workload

Another main responsibility of Human Resources is “resourcing”, especially for service-provider and project-oriented companies. HR Managers need to know if a project has the right amount of resources and the proper resources both in the present and in the future.

ArithmosCentrum allows HR Managers to see what resources are available for upcoming projects and plan accordingly. Project Managers also receive an automatic alert if a project is running off course or off budget and can liaise with the HR Manager to assign the proper resources.

4. Managing Productivity

HR Managers, in addition to Line Managers, are responsible for making sure employees are productive and meeting project deadlines.

ArithmosCentrum has a  TimeSheet function, which can be customized based on a company’s departments and operational tasks, which allows the HR Manager to track employee activities. Employees can enter daily hours and activities performed during the day which can then be printed monthly by the HR department.

Overall, the 21st century Human Resources Manager needs to manage employees in terms of logistics as well as productivity. The role of an HR Manager requires organization, effective communication and accessible information. As an integrated software system, ArithmosCentrum allows the HR Manager to organize documents, manage resources and stay in line with other departments.

human-resources-document-management