Time to Market

Challenge:

To ensure trials are completed expeditiously and with quality – done once and right the first time!

Solution:

eSimplicity Clinical Research helps eliminate the bottlenecks that impede many pre- and post-market clinical studies

• Simplify and accelerate data collection, cleaning, analysis and reporting
• Provide integrated management of people, processes and data
• Mitigate typical problems in enrollment, scheduling, and patient data collection via eSimplicity Schedule Management and Rule & Alert solutions
• Deliver “Adaptive Solutions” to sites that prefer to adopt eDC incrementally

Compliance

Challenge:

Success requires rigorous compliance with regulations, laws and ethical guidelines

• Regulatory Compliance (FDA, EMEA, etc)
• Operational Compliance (Sarbanes-Oxley)
• Ethical Compliance (OIG and State Guidelines on interactions with and payments to healthcare professionals)

Solution:

eSimplicity Clinical Research platform provides traceability, transparency and more complete documentation

• Secure, Web-based communication and support for Investigators and Sponsors
• Traceability of investigational work performed to payment eligibility and history
• Reduced overhead for financial inquiries – reduced sponsor headcount
• Ability to defend payments to healthcare professionals in conjunction with FDA Audits or other investigations
• Rigorous vigilance of 21 CFR Part 11, HIPAA & Related Regulations & Guidelines

Efficiency

Challenge:

Improve profitability and maximize effectiveness of your valued clinical and regulatory team. Eliminate waste, redundancy, re-work and ensure that clinical processes are high-quality and repeatable

• Major studies can cost $3-5M per year, over a three year+ period
• The National Institute of Standards & Technology estimates total R&D costs could be reduced by more than 25% through more efficient processes

Solution:

The eSimplicity Clinical Research platform streamlines key clinical processes to eliminate waste and lost time

• System control leads to higher quality and reduced time for review and re-work
• Earlier detection of data discrepancies
• Streamlined preparation and execution of CRO/Sponsor site monitoring visits through proactive review and analysis
• Reduced site monitoring time at sites -- improved investigator experience

Relationship Management

Challenge:

Manufacturers need strong relationships with surgeons -- not only to ensure an adequate supply of qualified investigators, but also to nurture advocacy among peers & thought leaders

Solution:

eSimplicity Clinical Research provides an array of features to improve and simplify the investigator experience

• Easy to use tools for patient enrollment, scheduling and data collection
• Minimize burdens on investigators
• Increasing likelihood of study involvement
• Streamlined participation may allow for reduced payments to investigators
• Transparency of the payment process including visibility into issues or data pending to obtain approval for payment
• Access to historical financial information – as a value add to investigators
• Streamlined communications with sponsor personnel
• Minimal disruption of other clinical/surgical activities at the site