Robust IT System at Veeda

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Introduction

As clinical trials IT expands in functionality, integration and ease of use, considerable improvements to clinical development processes and timelines can’t be far behind. Veeda offers robust software for electronic data capture (EDC) and data mining, internet-based portals for communication between clinical partners. The role of information technology within the clinical research industry is very important. Veeda’s ability to provide systems that are secure, robust and technologically advanced in accordance with present and future regulations within the industry is only second to the safety of subjects and volunteers.

IT Support

Veeda Information Communications Technology (ICT) Department supply technology support to all the users in units within the Veeda Clinical group at different sites throughout the world. Managing the whole infrastructure in-house via on-site staff and industry standard secure remote support tools for server, firewall and desktops 24/7/365 days a year. All IT staff are qualified to industry standards including certification with Microsoft®, Cisco®, Oracle®, ITIL®, the department also receive regular GLP and GCP training.

To enable swift fault diagnosis and resolution the ICT Department use the Information Technology Information Library (ITIL) framework to guide them and ensure problems and faults are systematically resolved. ITIL gives detailed descriptions of a number of important IT practices and provides comprehensive checklists, tasks and procedures that any IT organization can tailor to its needs. Audit tracking of faults, assets, solutions and procurement are maintained within a central secure fault reporting website providing one point of contact for all users. We have standard Service Level Agreements (SLA’s) for all faults which escalate in a timely manner to provide the correct level of expertise internally and externally to conclude problems as quickly as possible ensuring that safety, security and disturbance to operations are kept to the minimum.

Business Continuity Planning and Disaster Recovery

Business Continuity Planning and Disaster Recovery (BCP/DR) is a very important part of the business structure. The ICT department is instrumental in ensuring the security of data and backing up of information within the organization using proprietary software, regular verification and testing also takes place. A risk assessment for all sites has been undertaken and risk registers produced. The BCP/DR and risk registers are live documents which are constantly updated by everybody concerned which are reviewed by the management locally and globally. Veeda, as a group, has taken several measures and produced comprehensive supporting documentation, globally and locally to ensure disastrous events are proactively prepared for and systems in place to provide reactive procedures when necessary.

21 CFR Part 11 - Electronic Records; Electronic Signatures

The final rule provides criteria under which FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures. Part 11 (21 CFR part 11) applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by providing that electronic records may be used in lieu of paper records. Electronic signatures which meet the requirements of the rule will be considered to be equivalent to full handwritten signatures, initials, and other general signings required by agency regulations. All software in use within Veeda such as, Clintrial®, Trialworks®, Winonlin®, Watson® LIMS, SAS® and electronic data transfers are all validated in accordance with CFR21 part 11.

Data Protection

The data protection policy adopted throughout the Veeda group is primarily from European directives. These directives are used to form the same data protection across the group. Although not enforceable in local law in some parts of the group, Veeda take a single approach with some local variances if they are more stringent than the European version. The data and information policies are designed so that Veeda is ensured of data protection compliance and information protection, physical and logical security measures are in place which are policed by Information Communication Technology Department (ICT) of Veeda.

The following controls are defined in the above mentioned policies to ensure that appropriate controls are in place.

All the computers and servers at all sites of Veeda are protected physically by placing them with in the access control area.
All the computer systems and servers are logically secured. Firewalls are in place to restrict unauthorized access of data from out side.
Domain group policy is in place for all the units which ensure that all the controls are in place at site level.
Only authorized personnel have the access to critical information. They can access the information with correct user name and password only.
Usage of external storage devices is restricted.
All the sites of Veeda adhere to the local data protection laws.
In the countries where there are no data protection laws in place, data protection law of UK is adopted.
It is mandatory for all the employees to sign the confidentiality agreement before joining the organization.
Even though India does not have a general data protection law in place, there is an Information Technology Act, May 2000 in place. This act addresses breach of confidentiality as below.

“Save as otherwise provided in this Act or any other law for the time being in force, if any person who, in pursuance of any of the powers conferred under this Act, rules or regulations made there under, has secured access to any electronic record, book, register, correspondence, information, document or other material without the consent of the person concerned discloses such electronic record, book, register, correspondence, information, document or other material to any other person shall be punished with imprisonment for a term which may extend to two years, or with fine which may extend to one lakh rupees, or with both”.

Hence it can be stated that the all the data at Veeda is protected even though it is accessed by users from different countries.

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Veeda Clinical Research and Veeda Oncology are registered trademarks of Veeda Clinical Research, Inc.