Pharmica Consulting posted an interesting blog article about CTMS data integration and interfacing between clinical systems of CROs and pharma companies.
Read the full article at http://info.pharmicaconsulting.com/blog/bid/274064/Integration-of-CRO-Data-Your-CTMS-or-Mine.
The fall release of Allegro CTMS@Site, the clinical trial management system (CTMS) built for investigator sites and research groups, is rich with new features that aim to ease the workload of busy site staff. One key enhancement, much-anticipated by prospects and customers alike, is the addition of patient recruitment campaign functionality.
Sites are faced with many options for patient recruitment. Ads may be placed on media outlets such as TV and radio, social media may be utilized, or sites may develop their own call or email lists. However, tracking the impact of the campaign, response rate, and actual enrollment from all these sources can be difficult. Even more challenging, is comparing those numbers to the total cost of the recruitment effort and understanding which recruitment methods generate the highest return on investment (ROI).
The new recruitment campaign functionality within Allegro CTMS@Site helps ensure that the appropriate level of contact has been made and the next steps are clearly defined. Site staff can clearly see the recruitment progression from initial contact with a patient through registering them to the protocol.
In addition to traditional recruitment sources, Allegro CTMS@Site allows sites to leverage their existing patient registry to quickly and easily generate their own call or email lists for recruitment campaigns. Within the patient registry, potential matches can be identified on a number of factors that are best suited to the requirements of the protocol. By relying on their existing data, sites can spend their time reaching out to potential patients rather than gathering contact information.
With the addition of patient recruitment campaigns to the already highly adept CTMS, sites are able to streamline and simplify their workflows, increase efficiency, learn from their successes and failures, and ultimately increase their ROI. With a clear understanding of the number of potential subjects contacted versus the number enrolled on the trial and the resources spent, sites gain more visibility into negotiating future recruitment budgets.
– Global Healthcare Leader Becomes the Latest Pharmaceutical Company to Choose BioClinica’s Industry-Leading Clinical Trial Management System –
September 24, 2012. NEWTOWN, PA – BioClinica®, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, announced today that Sanofi (EURONEXT: SAN and NYSE: SNY), one of the world’s largest pharmaceutical companies, has selected BioClinica’s OnPoint as the company’s standard CTMS (Clinical Trial Management System). With this decision, Sanofi plans to utilize OnPoint CTMS for all clinical trial management activity.
Sanofi is the largest in a growing list of companies that includes other top ten pharmaceutical and medical device manufacturers to embrace BioClinica’s innovative clinical trial management system, making OnPoint the leading CTMS solution for forward-thinking companies.
“BioClinica is extremely proud that Sanofi has chosen OnPoint CTMS,” said Mark Weinstein, CEO of BioClinica. “We look forward to helping fulfill the long-term vision of Sanofi through the use of embedded and transformational applications. This is further evidence that our eClinical solutions are not only leading from a technology perspective, but that our people, products and services are some of the best in the industry.”
BioClinica’s OnPoint CTMS improves clinical trial management by helping sponsors easily centralize and share trial data. OnPoint’s unique Office-Smart design will maximize Sanofi’s existing investment in Microsoft technologies by letting users access, update, and report on clinical trial data from within the familiar environment of Microsoft Office and SharePoint. Using SharePoint as a collaborative portal, OnPoint’s web services integration with other trial management products provides an end-to-end trial management solution. This approach lessens the financial impact of trial management, greatly enhances user adoption, and helps avoid the pitfalls of outdated, legacy CTMS products.
“Providing an end-to-end clinical development platform that unifies the best available solutions is an important part of BioClinica’s approach to trial management,” said Peter Benton, President of BioClinica’s eClinical Solutions. “OnPoint’s ability to exchange information across multiple systems, including Sanofi’s choice of eTMF (Electronic Trial Master File), makes OnPoint the best choice for clinical trial management and demonstrates why BioClinica is the innovation leader in eClinical products.”
“I am confident that OnPoint is the right CTMS for Sanofi and will help bring new therapies and treatments to market faster,” continued Mr. Benton. “As part of Sanofi’s extensive evaluation process, we conducted a proof-of-concept implementation which demonstrated how OnPoint met Sanofi’s key business imperatives of collaboration, integration, and architectural openness.”
As a Microsoft Gold partner, BioClinica has long been known for its industry-leading integration with Microsoft technology. BioClinica was recently awarded a Microsoft Life Sciences Innovation Award for creating the OnPoint CTMS “Monitor Visit Report” which makes it easier for clinical site monitors to enter essential study information with or without an internet connection. Andrea McGonigle, national managing director for Life Sciences at Microsoft Corporation, stated, “BioClinica and Sanofi have both recognized the power of the Microsoft Platform and are using these technologies to build the future of how clinical trials will be run. The power of the Microsoft stack allows scalability and flexibility, and puts the information back in the users’ hands. Instead of monolithic database architectures, Sanofi will be empowered to ‘liberate their clinical trial data’ and make faster decisions.”
Oriam
The Paris based company Oriam, known for their CTMS products EC1 and eTrialManager is now part of Airial Conseil.
Airial Conseil itself is part of the REALDOLMEN group, which grew in the year 2007 out of the merger of the Belgian companies REAL and DOLMEN.
For more information, please visit the companies’ websites.
If you have decided to establish a CTMS system in your company you might think about the nessecity of having multiple installations or instances of this system.
More than one CTMS installation? Why that?
Of course you will ever work with one instance of your company’s CTMS to have one data basis to do reporting and get specific data. But there are other demands towards the implementation process of the CTMS that form the need to have more than one installation. Our proposal is to have three to four instances which does not mean that you will need four times the hardware – thanks to virtualization technologies.
Installation No 1: Productive Environment
This installation is the one productive environment. This system is where all your staff works in and enters real data. This system’s database is the source for all reporting.
Typically, this installation runs on the most powerful hardware of all four. Sometimes this system is even driven by a load balancing server to provide even more performance.
Installation No 2: Test Environment
Never stop a running (CTMS) system! Every change, every update, every bugfix has to be checked before it is implemented in the productive system (1) to avoid any problems. Therefore you should implement a dedicated test environment which is a copy of your productive environment.
Since this implementation is not very likely to be used by many users, it might be sufficient to run it on a virtal server.
Installation No 3: Training Environment
Having a technical solution is one part of the story, having your staff trained to use the system in the right manner is the other part. Independently whether you decide to have classical classroom trainings, e-learnings or a blended learning scenario you will have to have a installation of your CTMS which is espescially installed for training demands.
This system has to be well prepared to provide different training scenarios.
Installation No 4: Validation Environment
Most of the CTMS installations are nowadays validated which means that they comply with the regulations of 21 CFR part 11. To pass the necessary validation process it is a must to have a dedicated validation system to seperate the entries being made while working on test scripts from the productive trial data.
Of course it is possible that you have special conditions which make even more installations necessary, but the four mentioned CTMS installations are a well-founded approach for a professional implementation of your Pharma-IT landscape.
Pharmica Consulting based in New Jersey, USA offers consulting services for Clinical Trial Management Systems and other electronically supported R&D tools.
http://www.pharmicaconsulting.com
There is a funny video on YouTube where somebody explains Pharmica’s own approach for CTMS systems. Obviously they rely on Microsoft Sharepoint.