Products

Services

Solutions

Resources

About Us


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

Medical Writing

Quality, Flexibility and Focus

At eClipse, our medical writers have the experience, relevant education, and skill set to produce expertly-written, professional documents on time. We strive for scientific accuracy and efficiency of presentation, because of which all our deliverables undergo rigorous copy-editing and QC review to ensure that they comply with regulatory and stylistic guidelines. Our medical writers have the required scientific background and professional knowledge to help our clients produce the medical documentation they need to take their 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).

Familiar with relevant regulatory requirements, eClipse medical writers provide coherent and easy-to-read documents while maintaining scientific integrity in interpreting and presenting your clinical data.

Common Service Deliverables


• Informed consents and assents
• Clinical study reports (Phase I, II, III, and IV)
• Data and safety monitoring board (DSMB) reports
• Common Technical Document (CTD) sections
• Integrated summaries of safety (ISSs)
• Integrated summaries of efficacy (ISEs)
• New drug applications
• Investigational new drug applications
• FDA pre-meeting packages
• Investigator brochures in a concise and user friendly brochure
• Electronic Common Technical Document (eCTD)