For many years, phase IV trials were placed to deal with regulatory or commercial requirements.
It is no longer the case.
Translating the scientific and technological advances from the biomedical research laboratory into actual patient care practices has changed the post marketing scenario and then, the kind of projects pharma industry is claiming.
Real Life Trials, always in strict adherence to GCP allow:
Larger populations acceding to clinical research projects
More doctors participating as investigators
To evaluate access to treatment and compliance
To evaluate multiple age groups
To detect and register co-morbidities
To evaluate real life cases
To analyze concomitant medications
To satisfy regulatory agencies requests
To obtain strategically relevant “fist-hand” information
CREOS was a pioneer in Real Life Trials, and has a long-term track record of real-world evidence trial design including:
CREOS has been conducting Real Life Trials in LatAm for regionals companies and for Big Pharma Head Offices.
Strong validated tools are required to collect complete, reliable and accurate data in Real Life Trials. CREOS uses the proprietary system JAZZ ?Clinical®.
CREOS provides PF services solving every company and Project needs; due to regulatory requirements or strategic decisions.
Our PV service is supported by JAZZ ?Safety®, a validated tool in compliance with EMEA Directive 001/83/EC; Regulation (EC) No 726/2004 and Implementing Regulation (EU) No 520/2012, 21 CFR Part 11 and Disposition 5338/12 and ANMAT Good Pharmacovigilance Practices Guidelines/2009.
CREOS provides:
Full PV service: to Sponsors choosing to adopt an external provider
Managements and evaluation of reports and data for a range of products
Risk Management / Mitigation Plans
At CREOS we permanently update our services portfolio to reach client state of the art requirements, anticipating regional trends.
Besides CREOS’ has been managing phase I-II-III and bioequivalence projects, today premarketing clinical trials scenario, a whole new paradigm is on the road and requires a completely different approach.
Anticipating that trend, CREOS has been conducting trials under innovative designs during the past 12+ years.
CREOS is among the most experienced companies in dealing with this new paradigm in LatAm.
CREOS has large experience in designing, conducting and evaluating Bioequivalence Pharmacokinetics trials, under the "full-service mode".
Professional teams managing BE work under the umbrella of the School of Medicine, University of Buenos Aires.
We conduct BE trials in Clinical Pharmacology Units approved by the ANMAT.
Analytics are conducted in validate labs.
To accomplish the tasks that the new challenging scenarios propose us we manage our own technological tools.
We moved all our infrastructure to the cloud through the Office 365™ platform.
We develop customized electronic Trial Master File (eTMF) in a SharePoint™ framework.
We use our own eCRF/IRT and pharmacovigilance solutions: JAZZ® applications.
Electronic Trial Master Files are the current state of the art for managing and archiving clinical trial documentation.
Instead of out of the box universal model, we provide eTMF structured to fit your specific project.
MANAGING FILES THROUGH OUR eTMF ALLOWS:
CREOS provides eTMF management under the highest quality and safety standards aligned with current needs and requirements.
A user-friendly electronic case report form (eCRF) / study database application and infrastructure aimed for an “end-to-end” management of the clinical data from phase I to IV clinical studies (collection, review, coding and reporting).
The application was designed according to investigational team needs and based on years of experience in reporting/monitoring clinical data.
Jazz Clinical allows a significant reduction in number and complexity of queries and facilitates an efficient use of resources.
Drug supply management at Central depot / Site level.
Randomization & IP dispensing
A user-friendly pharmacovigilance database management system which enables an “end-to-end” drug safety management during clinical development and post-marketing phases.
Deep knowledge of our region, along with 30+ years of experience in clinical research field, allow us to easily conduct global trials in LatAm; always under the highest quality standards.
CREOS was founded and is led by doctors having strong academic background and more than twenty years of experience in clinical research in Regional and Global Pharmas and CROs.
That background, along with their experience as investigators allows CREOS’ management to understand actual needs and goal in every research program.
Dr Livio received his MD degree from Universidad de Buenos Aires and his Internal Medicine post-doctoral degree from the Argentine MoH. He was also educated in Administration and in Business Direction as well as in Pharmacology.
Dr. Livio has more than twenty years of experience in the Pharmaceutical and Clinical Research Industry and as Professor in Pharmacology.
Dr Flaster received his MD degree from Universidad de Buenos Aires and his Internal Medicine postdoctoral degree from the Argentine MoH.
Dr. Flaster has almost twenty years of experience in the Pharmaceutical and Clinical Research Industry. He was also evaluator at the Argentine Regulatory Agency.
CREOS’ upper management is fully involved in all projects
