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As experienced clinical trial data managers and technical developers who have managed paper-based and EDC-based clinical trials globally, we are acutely aware of how reporting has evolved from a "nice to have" element of clinical trials to a crucial element of business intelligence. We know that real-time, quality reporting facilitates effective decision-making.
We offer customizable, scalable and cost-effective reporting solutions. Our experience with different reporting/data analysis tools enables us to deliver customized solutions that fit the needs of clinical teams.
Bio-pharma companies have multiple systems that capture data for their clinical infrastructure – from EDC and trial management to pharmacovigilance. It's not surprising that in these complex technology environments, forward-thinking companies look to clinical-trial data reporting software to expedite review of clinical data by all key contributors to the clinical trial.
Our technical solutions team has extensive expertise with reporting from different Clinical Data Management (e.g. Oracle Clinical, Clintrial) and Electronic Data Capture (Rave, InForm) systems. We have experience using different reporting tools like Integrated Review™/JReview®, Business Objects, Crystal Reports, Cognos and SAS with the above mentioned CDMS and EDC systems. Our technical developers have thorough understanding of data models of these CDMS and EDC systems helping us to develop complex metrics and clinical study oversight reports in addition to clinical data reports.
Who better to deliver the full power of reporting capability from the above mentioned tools than a service provider with deep clinical trial domain experience and who; therefore,
At eClinical Solutions, a division of Eliassen Group, we understand the value of timely, role-based reporting of clinical trial data. Backed by years of management experience in pharmaceutical, biotechnology, CRO and service provider environments, our eClinical Solutions team understands end-user needs regarding reporting technologies and help the adoption and usage of customized reporting software within your clinical trial environment to achieve the best ROI.
The sooner that clinical team members review trends and analyze data discrepancies of your clinical-trial data, the faster you problem-solve and the faster you reach database lock. We provide your data managers, pharmacovigilence team, biostatisticians, clinicians and medical writers with clearly presented data that is viewed graphically, drilled down on and exported. This allows them to respond and problem-solve promptly because they share a singular view of the trial data, not a siloed view of data from several software tools.
We work with you and provide services that fit your business needs for your clinical-trial environment:
Our methodology is practical and results-oriented. The key steps are business-focused analysis, efficient project management, report building, thorough testing (including data validation and user acceptance) and complete knowledge transfer to the client. Documentation is completed as applicable during all phases. The methodology divides implementation activities into the following phases based on the solutions being provided:
For additional information, please hover over the individual process step.
Analyze Phase
During this phase, your requirements are gathered based on your business objectives. Detailed specifications are developed by analyzing the requirements and seeking clarifications. Recommendations are made based on our experiences and best-practices.
Build Phase
During this phase, the reports are developed based on your specifications. This is an iterative process ensuring that the requirements are met. We ensure that the reports are developed utilizing the best functionality available and considering the technical aspects such as performance, reusability, scalability…etc. Naming conventions are also used as applicable.
Testing
Thorough testing (including data validation and user acceptance) are performed before deploying the objects. We implement a thorough Quality Control (QC) process to ensure highest quality deliverables. All the deliverables are QC’d by Sr. technical developers before submitting for client approval. We maintain issue tracking logs and lessons learned knowledge base documentation on an ongoing basis to continuously improve our quality. These effective QC processes result in reporting solutions delivered with a low error rate and within agreed timelines.
Deploy Phase
In this phase, all the reports developed are deployed into the client's production environment. Deployment is performed using the client's conventions and standards if applicable. Access is provided to all the users in the most efficient method based on applicable security policies.
Train phase
In this phase, we ensure that the business users are trained to use the reports. A knowledge transfer is done to ensure objects can be changed easily and efficiently, if needed in the future.
Learn about all of our delivery models.
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eClinical Solutions, a division of Eliassen Group, provides Data Management Services, EDC Services, Statistical
© 2009 Eliassen Group All rights reserved
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