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Innovation.

The landscape is changing.   Industry is transforming, technology is evolving, and regulators have acknowledged this change.  Let ClinScape help you to architect your new clinical technology landscape.

Industry

Transformation

The life science industry is going through a change that is greater than any time in the past three decades.  The demands on clinical research organizations to decrease costs and decrease time to market have never been greater. 

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The industry has embarked on new initiatives to alter the existing paradigm including:

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  • Real World Evidence - leverage RWD to improve trial design, understand patient profiles, accelerate site initiation, detect safety signals, and provide synthetic study arms (or comparators)

  • Patient Centricity - Real-time patient engagement and enablement

  • Decentralized Trials - Virtual, siteless, or hybrid trials

  • Risk-Based Approaches - including risk-based monitoring

  • Evolving Standards - leveraging new and emerging standard from HL7, CDISC, TransCelerate BioPharma, CTTI, and ACRES.

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Transformation

Digital

Revolution

New tools and technologies are emerging at a fast pace to automate, accelerate, and improve the quality and throughput of clinical trials:

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  • Advanced analytics and data visualization

  • Operational and safety simulation

  • Enterprise integration

  • eSource for data collection

  • EHR and EDC integration

  • Artificial intelligence and machine learning

  • Mobile technology and wearables

  • Patient centric data capture

  • Social media

  • Patient portals and site portals

  • Mobile site monitoring

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Revolution
Regulatory

Regulatory
Evolution

The winds of regulatory change are upon us.  Regulators in both Europe and the United States have stepped up with new guidances and recommendations that allow flexibility in clinical research without compromising the integrity of the protocol or the data.  For example:

  • FDA guidance for use of electronic source data

  • FDA guidance for use of Electronic Health Record (EHR) data

  • FDA guidance for a risk-based approach to monitoring

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Innovation
Services

In addition to our standard service offerings, ClinScape can offer special services for those companies that want to take a leap forward with innovation:

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  • Industry vision motivational presentation

  • Collaborative advance (group brainstorming)

  • Industry benchmarking

  • Vendor evaluation and selection

  • Strategic roadmap

  • White papers and articles

  • Executive presentations

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Advise
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