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ERA Provides Benefits to IIT Investigators and IIT Sponsors

ERA Clinical specializes in Investigator Initiated Trials (IITs), supporting both Investigators and Sponsors. We deliver the platform, people, technology, and performance to turn Investigators’ Clinical Trial Concepts into reality. ERA has more than 25 years of experience in pharmaceutical and medical device studies and can help Investigators meet the challenges of independent research and to experience the rewards of discovery and publication.

ERA Clinical brings increased value to IIT programs. We work closely with Investigators and independent of Sponsors, preserving the nonintrusive posture required by regulatory agencies. ERA works on behalf of IIT Investigators by providing vital support services that improve the quality of Investigators’ performance and maximizes the potential for peer-reviewed publications and scientific presentations.


Investigator Benefits
 
ERA Services
 
Sponsor Benefits
Increases the likelihood of gaining rapid Sponsor approval and grant acceptance.   Collaborates with Investigators to design programs that are based on sound science and logical hypotheses. Studies will be consistent with Sponsors’ lifecycle strategies and objectives and will always meet industry standards.
  Ensures the focus is on good science and sound protocols with a clinical trial platform that can deliver quality data and a bring value to your IIT program.
   
Your study will become a valuable asset to your practice (and the Sponsor) without added burdens or increased expenses.   Helps Investigators evaluate study feasibility and formulate strategies regarding:
  • Subject recruitment and referral strategies (if needed)
  • Allocation of adequate resources to complete the study on time and in budget
  • Dedicated personnel, space and equipment
  • Planning Investigator’s time and effort consistent with his/her practice, teaching, and other responsibilities
  Increases trial efficiency, improves control over study budgets, and avoids delays and cost overruns.
   
Confidence in and control over your data management process through a simple, cost-effective, yet comprehensive data collection tool that can be used for a single-site or multiple-site capability.

Assures you of complete, quality clinical data for developing manuscripts or presentations.

Demonstrates highest level of professionalism and produces quality data for analyses.
  Offers Investigators access to ERA’s state-of-the-art electronic data collection (EDC) system (ERA-Data™), which is web-based, secure, compliant with all FDA regulations, and allows for “risk-based” central monitoring.   Ensures quality data, consistent with the highest industry standards and improves the opportunities for a strong publications program.

ERA-Data can be used in multiple site and global IITs.
   
Meet your regulatory compliance requirements throughout the study.

Gain confidence in knowing you have highly experienced clinical research experts supporting your efforts, answering your questions, and guiding you in the right direction.
  Provides Investigators with expert guidance, consultation, and training to minimize problems and increase success, while maintaining the required regulatory “firewall” between Investigators and Sponsors.   Greater confidence knowing that the experts from ERA are involved in the trial, always meeting industry and regulatory standards.

Conflicts and problems are addressed promptly, using best practices for rapid resolution.

ERA becomes an extension of the site staff to improve quality and results.
   

Start you next IIT with the knowledge that the clinical trial experts at ERA can support you every step of the way.


ERA offers a broad range of clinical trial services


ERA offers a broad range of services to Investigators to increase success of Investigator Initiated Trials. To determine which services you need for your next study, contact ERA Clinical before you begin your grant application. Call 877-777-ERA1 or respond using the convenient form on our Contact Us page.

Strategy and Logistical Services

  • Grants and Budgets
  • Recruitment and Referral Strategies
  • GCP and EDC Training
  • Audit Preparation

Data and Statistical Services

  • Database Design
  • Electronic CRF
  • All Standard Dataset Outputs
  • Biostatistics Planning and Analyses

Clinical Services

  • Study Design and Protocol Production
  • Document Preparation
  • IRB Submission
  • Informed Consents
  • Risk-based Central Monitoring
  • Final Study Report
  • Publication and Presentation Programs
Investigators:

To discuss how ERA can assist with your next IIT, please call us at 877-777-ERA1 before you submit your grant proposal to a Sponsor.

Sponsors:

Your Medical Affairs Team may want to use ERA as a resource to bring greater value to your IIT program. Call us at 877-777-ERA1 for more information about how we can help. You may also want to know more about our other CRO Services. (Learn More)

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IIT, IIS, IIR, IIS, ISR, IST, KOL, MSL, medical affairs, Phase IV, investigator initiated trials, post marketing, post marketing, key opinion leader, medical device; ERA Clinical is the CRO for Investigator Initiated Trials, medical Device and Streamlined Clinical Trials. Quality, Cost & Speed, along with innovative systems & technology offer unparalleled value.