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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

Clinical Trial Services

Big CRO capabilities with the flexibility and cost-effectiveness of a mid-size CRO

In delivering our techology we have developed close relationships with mid-size CROs throughout the United States, Europe and now Asia. To support the successful implementation of our technology platform we can match your study specifics with the expertise of our partner CROs. If you’re running a device study we have partners specialized in devices, if you’re running an oncology study with sites in Europe and Asia we use data management partners specialized in oncology and clinical operations partners with the local experience in Europe and Asia. This way you get the global reach and local expertise of the larger CROs, while maintaining the cost-effectivness and flexible service delivery of a small CRO.

Leveraging our project management experience we provide you with single-point accountability so you may have confidence in knowing when critical events arise during your study, they will be handeled with efficient coordination. Our project managers drive internal resources for the expert database and eCRF design, lab and data imports and data extracts, while coordinating partner resources for data review, biostatistics, medical writing and clinical operations.

Project Management


Effective project management has always been a cornerstone of our clinical services. We have created efficient processes to deliver results of unparalleled quality. Keeping the client at the core of all our decisions, eClipse sets itself apart with its transparency, access at every stage and open communications hand-in-hand with unmatched speed and flexibility. So, whether your clinical trial is a one-center Phase I study or a Phase II –IV multi center study, eClipse’s data management team will stand with you every step of the way paving the way to a relationship for success.

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Data Management


Our seasoned EDC experts bring over 60 combined years of experience in delivering your electronic database and CRFs. The database build, eCRF design, data imports and data extracts will be optimized according to established best practices and industry standards like CDISC (SDTM, ODM.) For data review, query resolution, coding, adverse event reporting and communication with the sites trust our data management partners with experience ranging from 12 – 30 years of data management experience in various therapeutic expertise.

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Biostatistics


Our teams of experienced biostatisticians and SAS programmers have built a reputation of industry expertise and excellence by being trusted partners that produce comprehensive, high-quality, timely analysis and reporting of study results across a broad range of therapeutic areas. We have extensive knowledge of experimental design, statistical methodology, and global regulatory requirements.

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Medical Writing


We ensure that the medical writer assigned to each project team has the required scientific background and professional knowledge to produce the highest quality medical documentation needed to take a client’s drug study to the next phase. They are there for you at any point in your product development lifecycle, from the clinical development plan to individual clinical study protocols, reports and manuscripts, to regulatory submission documents (including eCTDs). Trust that we demand scientific accuracy and efficiency of presentation, and subject all our deliverables to rigorous copy-editing and QC review to ensure that they comply with regulatory and stylistic guidelines.

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Clinical Operations


We continue to add regional clinical operation specialist around the world to our list of partner services providers. Now including Asia, our partner program provides us strong presence in India, China and Japan. Whether its site management, monitoring, supply distribution – our hybrid project teams develop integrated plans involving all stakeholders to ensure the business relationship succeeds. From start-up to completion, performance is monitored and reported regularly and measured against contractual timelines to assure project success for our clients.

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