Phase IV – Post Sale


CREOS is among the most experienced companies in managing phase IV trials.

Several years ago we understood the global trends in clinical research and started designing and conducting peri-approval trials in our region.
Our experience in Pharmaceutical companies allowed us to understand that a successful launching needs extensive clinical support, different to that provided by earlier phase’s trials.
Our deep knowledge of the regional environment allowed us to develop phase IV projects tailored to our client’s needs and possibilities, reaching international standards and strictly following GCP.

Observational and Non Intervention Trials (NIT)
We have been conducting NIT for almost ten years.
As a pioneering company in managing NIT, we developed full service programs, including the training of investigators, already experienced in “classical” phases, in the new paradigm.
Several of the large NIT we have been conducting allowed us train non-experienced PIs, delivering on our mission by including a big number of sites in big projects.
From the concept sheet to the final report we manage NIT keeping the goal in mind and applying the highest GCP standards during the process.
As a flexible and innovative company, we are among the first in managing remote monitoring.
We developed tailored eCRF and proprietary systems specifically for phase IV.
Our trained CRAs are able to understand the differences between phase IV and earlier phases as well as how to remotely conduct sites.
Initially linked to huge NITs, we are among the first companies in managing remote monitoring

Epidemiology Assessments and Pharmacoeconomics
Our experience in the Pharmaceutical Industry and in Health Administration allows us to examine the effect interventions on clinical and economical outcomes.
Most of our reports can be translated into concrete actions by our client.
A strategic alliance with a market research company provides us with trained interviewers, allowing a fast launching of efficient programs.

Pharmacovigilance – Risk Management Plan (RMP)

We can cover the safety department role for companies lacking their own in-house resources.
We developed a specific IT platform flexible enough to cover regulatory requirements or operational needs from our client.
We offer a full service Follow up and Report Adverse Reactions.

According to EMEA Directive 001/83/EC; Regulation (EC) No 726/2004 and Implementing Regulation (EU) No 520/2012 and under strict observance of ANMAT DIsposicion 5338/12 and ANMAT Good Pharmacovigilance Practices Guidelines /2009; we provide full service programs for Risk Management once product is already launched to the market for both, Programs compulsory required by the Agency and for the Sponsor’s strategic decision.

Real Life Trials
Several years ago we identified this trend and need, even before it became widely accepted
That view allowed us to be among the first companies in the region recommending and conducting these procedures.

Trials to support marketing claims, new indication or label changes

We started managing these needs more than twenty years ago, covering local and regional pharmaceutical needs.
In understanding the scenario, we organize and lead the most efficient project, tailored to our actual client’s needs.

CREOS adopted a friendly proprietary system (JAZZ®) for e-CRF, Safety and IWRS from a strategic partner.
By using the proprietary system our professionals provide full Pharmacovigilance Programs as well as safety management for clinical trials.

JAZZ SAFETY database
Web-based drug safety database for full service Pharmacovigilance
    • FDA 21 CFR Part 11 compliant
    • Data elements compatible with ICH E2B (R3) standards
      • Processing drug safety information from any source
      • Highly scalable safety process
      • Case management through a defined workflow
      • Duplication check function
      • MedDRA browser integrated
      • Export of CIOMS forms for notification to the Agencies
        • Medical Evaluation module
        • SAE form collection (24/7 fax also available)
        • SAE processing in the drug safety database, including medical terms codification (MedDRA), drug codification (WHO-DD) and narrative writing
          • Periodic status reports
          • SAE quality monitoring
          • Query management, contact & follow up
          • Individual SAE cases Medical assessment and recording
          • SAE monitoring and periodical cumulative safety assessment

JAZZ EDC
Web-based eCRF
            • 21 CFR Part 11 compliant
            • Web based; doesn’t need the PI installing any program
            • Works under Linux and under all Windows versions
            • Run under all browsers (Chrome, Explorer, Firefox, others)
            • Cab be managed in Spanish, Portuguese and English
            • Help desk available 24/7
            • Tailored design and implementation
            • IWRS integrated
            • Design and implementation of SAE forms, safety data base management, queries resolution, CIOMS
            • Data export to the server indicated by the Sponsor
            • Customizable edit checks
            • Query management module incorporated
            • Allows pages verification (monitor) / approval (PI)
            • Generation of reports (e.g. query reports, audit trail)
              • Training for sites and CRAs

JAZZ IWRS

System’s main features:

                • 21 CFR Part 11 compliant
                  • Centralized randomization and treatment allocation
                  • Patient status tracking (e.g, screened, randomized, withdrawn) and dynamic e-mail notification to site, central lab., sponsor, etc.
                  • Allows a real-time monitoring of the site recruitment status for the sponsor
                  • Subject unblinding
                  • Management and communication of IMP inventory at the sites
                  • IMP expiration dates monitoring and automatic delivery of IMP usage reports
                  • Integration into eCRF

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