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EDC

Electronic Data Capture
Drug development companies are increasingly using technology to make clinical trials more efficient

CTMS

Clinical Trial Management Products
MPower focuses on providing software frameworks that empower clinical Research

CDMS

Clinical Data Management Services
eClipse can support your build project and train you on best practices

Data Management

Constantly Striving to Move the Study to Closure

The hardest part about clinical trials is the patient recruitment. Once you get the patients into the study, you don’t want the clinical teams slowing things down. That is why at eClipse we are constantly driving to improve efficiencies in the overall process. We balance our experience with the right technology for specific types of studies. Where others deliver databases in 6-8 weeks, we deliver in 3-4; while others have cumbersome review mechanisms our products streamline review; while others match coding operations with particular studies we not only code all studies at one time – but also safety verbatim that arrive after a drug has been approved.

Our project managers assemble a data management team customized to your specific clinical requirements. We follow precise, proven procedures to:

Build your EDC database

eClipse resources leverage their extensive EDC design experience to design your database and electronic Case Report Forms. Data extracts and data imports are fully specified and implemented within eClipse EDC. Data extracts are available in multiple formats including CDISC ODM and SDTM formats.

Annotate eCRFs

Essential for dataset handoffs, eClipse staff prepare annotated eCRFs mapping the online eCRFs to the fields of the defined datasets.

Edit Check programming

Optimizing the balance of automated checks and data management review, eClipse data management staff thoroughly identify where automated edit checks will have the largest impact. Like other EDC systems our technology lets us program multi-variate checks within a page or across a visit. However, we bring data cleaning and consistency to a new level by permitting inline checks across protocol or even across applications.

CDISC Implementation

We keep track of the evolving requirements of the FDA so that you always have access to submission-ready information. We remain current with the latest CDISC standards converting our data into ODM, SDTM and ADam datasets.

Medical and Drug Coding

Using the latest version of MedDRA and WhoDrug , we identify codes for adverse events, medical history and concomitant medications for your clinical trial. We have experience managing multiple versions and upgrading versions at the end of the study. Since we use eClipse Coding, our activities and coding assignments are completely transparent and available for viewing over the internet.

Quality Assurance procedures

At eClipse Quality Assurance is an integrated practice that promotes excellence by ensuring adherence to our processes. Our focus on quality has been honed by years of specialized data analysis and amangement as well as a throuugh grasp of Good Clinical Practices and FDA requriements and processes. Every client benefits from our QA experience in disciplines including clinical data managment, biostatistics and SAS programming.