Changing Business Model Trends: the Cloud and Compliance

cloudThis week, Arithmos looks at the cloud solutions for the pharmaceutical, biotech and clinical trial industry as part of a presentation given by Chief Operations Officer, Stefano Piccoli, on the future of IT quality and compliance at the GIQAR conference in Italy. 

According to the National Institute of Standards and Technology, cloud computing is defined as “a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing records that can be rapidly provisioned and released with minimal management effort or service provider interaction”.

The cloud delivers information and communication technology as a service, and benefits include on-demand, scalability, flexibility, self-service and pay-as-you-go options.

cloud structures

IT Compliance in the Cloud

Healthcare companies have concerns about cloud computing: it may not be secure, cannot meet privacy requirements, cannot be compliant, current regulations are not adequate.

There are numerous compliance issues:

  • Validation/Part 11 criteria for the cloud environment and client applications hosted in the cloud
  • Maintenance of validation for the provider’s cloud and the client’s application
  • Security/Access controls for provider’s cloud

What is needed in terms of compliance in the Cloud?

The first step would be to implement a Service Level Agreement which outlines the intended use of the cloud, responsibilities associated with the intended use and who will define these responsibilities.

The next step would be to implement the following procedures:

  • How will computer system validation be handled?
  • How will disaster recovery be handled?
  • How will the Installation Qualification be handled?
  • How will change control be handled? Is there a standard set of SOPs?
  • How will encryption be handled?
  • How will regulatory inspections be handled?

There are no special compliance exceptions for cloud computing, and compliance control measures for internal computer systems apply to externally hosted systems as well. While systems supporting regulated activity can be outsourced to cloud providers, the client must still consider compliance responsibilities.

Computer System Validation and Part 11 compliance will depend on the type of cloud being provided, the intended use of the cloud environment, criteria defined in the Service Level Agreement and good documentation.

csvArithmos and Computer System Validation

Arithmos has extensive experience in the computer system validation of GCP applications and can support customers in planning, conducting, reviewing and maintaining the validation status of their applications.


Related Links

Best Practices: Implementing Computer System Validation

Computer System Validation: Comparison between 21 CFR Part 11 and EU Annex 11



Update on EU Data Transparency Legislation: Centralized Storage Solution

l_1171_ema-transparencyThe European Union is inching closer to putting its data transparency legislation into place for clinical trials. The European Medicines Agency (EMA) has already released an official document detailing the legislation and it’s timelines. The data transparency policy comes into effect on 1 January 2014 and Sponsors applying for centralised marketing authorisation should note that any clinical trial data submitted after 1 March 2014 is subject to this policy. 

How can Sponsors prepare for the impending legislation from a technology perspective? One solution would be to centralize data storage to allow for better data traceability and immediate results. In the clinical trial environment, traceability means knowing where clinical data is located and how information is derived.

In a decentralized scenario where data is stored across multiple CROs, there are several disadvantages including a variety of EDC vendors, replying on multiple IT vendors, little or no traceability, complicated data pooling and problems with biometrics quality.

Centralizing data storage produces several advantages:

  • Information in a single point of storage/database
  • One audit trail data source
  • Same location for study and derived data
  • Traceability is possible from beginning to product submission and market authorisation
  • One portal for real-time reports
  • Reporting availability on devices: laptop, tablets, smartphones, etc

Benefit of centralizing storage of clinical data - GA02

Centralized Storage and Data Transparency

When the EU legislation takes effect, Sponsors will need to be able to produce data for publication in an EU database. Centralizing hosting means Sponsors only have to maintain and back up one system. Therefore, it is easier to apply logical and physical security procedures  to keep data confidentiality under control. When it comes time to submit data, Sponsors can easily transfer data while ensuring data privacy.

In preparing for the EU data transparency policy, centralized storage can produce additional benefits like greater efficiency and cost reduction. Review cycles can be reduced with standardization, and the value of intellectual property is enhanced by having all data in one database; indexed, traceable and transportable.

In terms of costs, Sponsors avoid paying for multiple global library set up, programming macros and validation checks.

Data-Network-concept31Of course, many pharmaceutical companies are lobbying against the EU policy with the fear that data transparency will ruin intellectual property and innovation. Many are also concerned with patient privacy and whether data mining will make personal patient data more accessible. Keep following the Arithmos blog for more updates on this legislation. To learn more about centralized storage, email us at 

Technology Solutions for a Centralized Biometrics Approach

Choosing an appropriate outsourcing method for clinical trials also means choosing the right technology solutions to enhance operational efficiency and reduce costs. An alternative outsourcing method which is gaining popularity is to centralize clinical trial data with one specialized vendor for all studies related to a single product or compound. Benefits include standardized data formats, improved traceability, greater leverage of work, and most importantly, a significant reduction in costs. 

If one study team is assigned to trial design, data management, data analysis and medical communications from the start, common data standards can be applied. However, Sponsors should also analyze technology capabilities before committing to a centralized approach as the right technology, secure data storage and accessible reports are key to success.

The following is a cost benefit analysis for technology solutions in a centralized biometrics scenario:

centralized storage

Centralized Hosting: Applying a centralized biometrics strategy also centralizes data storage using a single database for all clinical data. This means there is only one database to maintain and one repository to back up. Security procedures can easily be put into place and data confidentiality is ensured, and data is easily transferable to the Sponsor via web portal containing metrics and reports.

omniscience-appEDC Solutions: Sponsors can also save on EDC licensing fees and database set up when centralizing storage. Arithmos can offer a variety of EDC solutions from low-cost, web-based solutions to more sophisticated and intuitive systems depending on study budget and Sponsor expectations.

Pharmacovigilance Applications: Likewise with PhV applications, Arithmos provides licensing and setup support. We have an Oracle AERS solution for product safety monitoring and compliance to help manage adverse events and reduce risk. Through an Oracle Business Process Outsourcing (BPO) agreement, CROS NT can optimize safety reporting and data visualization through direct access to safety databases or Oracle Business Intelligence.

Data Visualization to Data Transparency: Managing Your Clinical Data

EU-Clinical-Data-Transparency-One-Step-Closer-as-Draft-Regs-Approved_strict_xxlThe European Union is one step closer to approving legislation on data transparency which would require that companies provide detailed summaries of clinical trial data be published in an EU database accessible to the public. Once marketing authorization has been granted, clinical trial data will no longer be confidential, and Sponsors can face strict fines for not complying. The proposal is expected to take effect in 2016 with support of the European Medicines Agency.

Clinical data visualization can be an important component for Sponsors conducting trials in Europe who need to make more informed decisions and make sense of clinical trial data which will now be shared publicly. Arithmos shares 4 reasons why clinical data visualization is invaluable for Sponsors.

1. Access to Data in Multiple Databases and EDC

Conducting a trial generally leads to data being spread across multiple databases, including EDC, CTMS, ePRO, safety databases etc, and such databases can be spread across multiple vendors. Data visualization tools allow the ability to drill-down data and click-through multiple levels of detail, allowing for the analysis of specific subsets and sub-populations.

2. No Technology Required
Data Visualization tools today are generally cloud based, meaning costs can be kept under control since Sponsors can “rent” software per study. Reporting tools are optimized for smartphones and tablets.

3. Ad-Hoc Reporting and Dashboards

Using data visualization tools, clinical leaders can see information that is beyond the capability of the CTMS report set. Customizable dashboards allow the clinical team to create ad hoc reports on site performance, data quality, safety and efficacy, drug supply and patient management.


4. Real-Time Results

Perhaps the biggest benefit to data visualization, clinical metrics from multiple sources can be analyzed in real time. Decision makers can identify and fix underperforming sites and make crucial decisions on study progress.

Case Study: Business Intelligence Using the iPhone and iPad

Arithmos and Data Visualization: Arithmos recognizes the importance for Sponsors to have easy and immediate access to data. We can create a web portal so our customers can view study progress and have access to real time clinical and safety data reports.