Some of the highlights include:

• Security enhancements to meet 21 CFR part 11 requirements
• Using iDataFax to import data records from unformatted data files
• Using iDataFax to import CRFs and other patient documents from PDF files

Study-Portal is a generic Trial Portal which is developed by Thorin. The Portal is a secured web environment which allows User-based & Role-based access to Study information. The Portal is able to handle and share information on multiple trials. Its purpose is to facilitate two-way communication and information exchange between all parties in a trial (Sponsor, CRO, Site and Patient).

In cooperation with Factory CRO, we have identified a number of areas where Sponsors and Sites can benefit from web-enabled access to Study information. We will be presenting examples on two of these areas.

A first section is related to Site Management, Patient Enrollment and Data Quality. Information from the Centers DB is integrated with the Profile section of the Study-Portal, allowing authorized users to browse participating sites. Information from DataFax reports like DF_PTvisits or DF_CTqcs is extracted and used to allow for more flexible information access and creating web-pages like "Best enrolling sites", "Data Quality per Site" or "Most Problematic Plates". We expect that by providing Sites with more timely and online feedback, in combination with using the Portal's Blog and Forum facilities by both DM staff and Site personnel, the initial data quality can be enhanced, thus resulting in a lower Query rate.

A second section is related to the handling of QC notes. All QC notes from DataFax are exported to the Study-Portal. Based on their User account, any user (e.g. a Site) will have access to a subset of the QC notes. Thus by logging in, a Site will only have access to their "own" QC notes. This provides a third transmission alternative, next to emailing or faxing of QC reports. The QC web page allows to Sort or Filter QC notes on any relevant item and thus provides a flexible method for Sites to handle QC notes. Once QC notes are sorted/filtered, like sorted by Plate or Patient Id, the resulting report can be printed. It goes without saying that the advantage of this web-based access to QC information is mostly for non-iDataFax users.

We will be discussing the methods we are using to securely get data from DataFax into the Web portal, as well as showing some examples of DataFax based Web content as accessed through the Study-Portal.

These non hypothesis driven data collection projects generally fail to meet our criteria for developing a DataFax study. In many of these simple data collection projects the extra features of a clinical trial grade data collection system are more of a hindrance than a benefit. As a response to these requests for simple unaudited, non quality controlled data collection systems, the Clinical Research Unit has been deploying simple java based, web delivered, relational databases. Although response has been positive, a number of clients who had historical experience with DataFax have indicated that retaining the ability to fax data in would make these simple solutions even more desirable.

The objective of this presentation will be to outline how the Clinical Research Unit leverages DataFax OCR and fax receipt capabilities to accept faxed data into alternative data collection systems.

• To upgrade or not to upgrade: issues that affected the timing of our upgrade and the version of DataFax
• Training, and the use of Camtasia to develop training modules
• Changes required existing studies and the decision to move all studies at the same time
• Streamlining our security model
• Installing DataFax instances on SLED VMs
• Bugs, features, gotchas and work-arounds
• Staff reactions to DataFax 4.0

The retooling of DataFax was in part driven by the industry demand for Electronic Data Collection (EDC). Although EDC capability is now an integral part of DataFax, the solid underlying technology has meant that fax-based data collection endures, thereby slowing the adoption of the iDataFax toolset. At DF/Net, production studies are still primarily managed with 3.7 vs. iDataFax (the latter being used for 8% of active studies which represent just 5% of the company's 2.75 million primary records). Nevertheless, as all new and developing studies will be launched in iDataFax, the balance will begin to shift. In anticipation of this change, DF/Net is looking at how it will utilise the new capabilities of iDataFax for data management.

This paper is a joint effort of a CRO and a small-time consultant, both using DataFax exclusively for setup and management of clinical trials. In an effort to promote evolution rather than resistance, we will consider some of the philosophical differences between the old and new interfaces, with a focus on how the latest iDataFax tools may be leveraged for fax-based studies.

Objective:
Share experiences of planning, preparation, logics and actual inspection conduct:

Planning:

1. Planning started 4 months before the announcement (6 months before the inspection) - Assignments, Schedules, Facility

Preparation:

1. Included Mock Inspections - to identify weaknesses and gaps
2. Assignment of tasks to close the gaps
3. Traceability of processes that occurred 5 years ago
4. Assessment of Validation Documents for computerized systems

Logistics:

1. The Inspection Room with -
   a. The Inspection Team (Lead, Requestor, Note Taker);
2. The Ready (War) Room with -
   a. The Ready Room Team(s) - Lead, Request Receiver, Subject Matter Experts, Runners)
3. Supplies - copiers, paper
4. Study Files and Documentation

The Inspection:

1. A joint Inspection - pros and cons
2. FDA protocol
3. EMA protocol
4. Line of questioning
   1. Sample questions
   2. What they got stuck on
5. Closing

Key Messages:
As a true Quality Professional, I don't believe in audit preparation - our operations need to be "audit ready" at any time. Having said that, inspections are often conducted on studies that have occurred in the past so some work may be necessary to prepare - retrieve from archives; consolidate documents and review past processes and practices. It is also important to provide the participants with some experience and expectations of the process.

We cannot turn back the clock or change history - but we can review what occurred, and identify what we can do to improve. Agencies are looking for "patterns of practice". Our review of our file should confirm that we can show positive patterns and practice in line with the requirements.

Strategies:

1. An inspection is totally reliant on documentation. Start with a solid Trial Master File for your baseline. Know what you should have and what you do have - reorganize if necessary.
2. Have staff review the conduct of the study and understand the processes that took place at the time. Identify areas of weakness e.g. minutes of key meetings are unavailable, approvals not evident.
3. Conduct Mock Inspections to train staff on inspection scenarios to make them more comfortable.
4. There is never too much preparation.

Conclusion / Discussion:
Prospectively, do it right today - can't change history and it does take more time later. Regulatory Inspections are different than Sponsor Audits. Most importantly, there is more at stake and the inspectors are not stakeholders in the process. The inspection covers a much larger scope as well making it more intense.

1. Challenges we face at some remote sites
   1. Desktop lockdown (no 3rd party installs)
   2. Network lockdown (port 443 firewalled)
   3. IT Culture and language barriers
2. Technologies explored
   1. Thorin USB solution (virtual desktop, USB stick delivered)
   2. Anyware ROAM (Java based, Web SSL 443)
   3. Window 2008 Terminal Services (Remote Desktop ActiveX)
   4. Laptops with Broadband wireless
3. Benefits and drawbacks
   1. Ease/difficulty of implementation
   2. Ease/difficulty of use

Typically, in most data centers, the system resources utilization is low. It uses a mere 5-25% of resource consumption that means 75 - 95% has not been utilized while cost of maintenance and management is still high.

In the past, a critical application deployed in its own machine, it led to the heavy price, over population of hardware power, space and bandwidth problem management and cooling system. BIOPHICS, Faculty of Tropical Medicine, MAHIDOL University has been adopting SUN Logical Domain (LDOMs) since 2009.

Logical Domains (LDOMS) is a technology for server virtualization that enables users to allocate system resources, such memory or devices into logical groupings in order to create multiple virtual machines. Nowadays, our 4 physical DataFax servers are put into just a physical server. Obviously, there are many benefits, however, running DataFax on the LDOMS environment, there are some issues to be carefully considered.

The presentation will cover the following issues:

1. Virtualization Technology focused on LDOMS.
2. Pros & Cons
3. Distinctions when compared to Solaris container or Zone.
4. Experiences will be shared
   • Migration to LDOMS
   • Some problems found when running DataFax
5. Online technical resources

Conclusion, virtualization is a technique that enables an organization to get most performance and utilization of servers. The obvious benefits of virtualization are cost reduction, easier IT system management and certainly, nowadays people are more likely to consider on global warming or green technology, the virtualization is a way to responsible for.