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SOLUTIONS FOR CLINICAL RESEARCH

Our trial model are the coming ones, Now Marketplace is Clinical research place, Jazz system, Latin-America is our home and we know it

MASTER ADAPTIVE - BASKET DESIGN - UMBRELLA PROJECTS, NON INTERVENTION TRIALS - EPIDEMIOLOGIC - REALWORLD EVIDENCE, eDC - eCRF - PV - IWRS, REGULATORY - SITES - LANGUAGE

REAL WORLD EVIDENCE

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:

  • Observational and Non-Intervention Trials (NIT) 
  • Epidemiology Assessments 
  • Pharmacoeconomics evaluations 
  • Real Life 
  • Marketing claims 
  • Label changes
  • Pharmacovigilance Programs 
  • Risk Management / Risk Mitigation Plan (RMP) 
  • Pharmacovigilance

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®.

Pharmacovigilance

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

CUSTOMIZED PROJECTS

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.

To cope with the current prospect, we develop and conduct:

Master Adaptive

A design using a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple sub-studies, allowing for efficient and accelerated drug development.

Basket design

A design evaluating a single investigational drug or drug combination in different diseases or populations.

Umbrella Projects

A protocol designed to evaluate multiple investigational drugs administered as single drugs, or as drug combinations in a single disease population.

Platform Projects

A design allowing to study multiple interventions in a disease or condition, with interventions entering and leaving the platform on the basis of a predefined decision algorithm.

CREOS is among the most experienced companies in dealing with this new paradigm in LatAm.

Bioequivalence

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.

INNOVATION & TECHNOLOGY

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.

eTMF

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.

The final tool is compliant with FDA, EMA and regional standards and follow GAMPs directions.

MANAGING FILES THROUGH OUR eTMF ALLOWS:

  • Efficient use of resources 
  • To minimize printing and carrying 
  • Access restricted to authorized personnel  
  • To review/approval in real time  
  • Automatic real-time back-up 
  • To satisfy Personal Data Protection directives 

CREOS provides eTMF management under the highest quality and safety standards aligned with current needs and requirements.

JAZZ CLINICAL

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.

FEATURES
  • Web-based: only a desktop PC/laptop with an internet browser + internet connection are required
  • Fully validated
  • 21 CFR Part 11 compliant
  • Multilingual support (Spanish – English – Portuguese)
  • Flexible for any clinical study design
  • Dashboard with real time-information including enrollment and eCRF completion status
  • Electronic query management tool
  • Data validation checks
  • Electronic SAE reporting
  • Electronic IND/SUSAR distribution
  • eCRF screens verification (by monitor) and approval (by principal investigator)
  • Allows centralized monitoring
  • Protocol deviation management module
  • Helpdesk

Jazz Clinical allows a significant reduction in number and complexity of queries and facilitates an efficient use of resources.

IRT module integrated

Drug supply management at Central depot / Site level.
Randomization & IP dispensing

JAZZ SAFETY

A user-friendly pharmacovigilance database management system which enables an “end-to-end” drug safety management during clinical development and post-marketing phases.

FEATURES
  • Web-based: only a desktop PC/laptop with an internet browser + internet connection are required
  • Fully validated
  • 21 CFR Part 11 compliant
  • Multilingual support (Spanish – English – Portuguese)
  • Dashboard with real-time case management information
  • Export ICSRs in standard formats (e.g., CIOMS, e2b XML)
  • Case management through an automated workflow to optimize efficiency and effectively manage increasing case volume & complexity
  • MedDRA browser integrated
  • Electronic AER forms for remote case data collection (e.g., by call center, sales representatives, health professionals, patient/consumers, investigators)
  • Case duplication check (automatic)
  • Auto narratives
  • Regulatory compliance management module
  • Helpdesk

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.

Regulatory Affairs

We are in close contact with regional regulatory agencies.
We have a dedicate team to stay fine-tuning the evolving field of rules and local requirements.

Sites

We have built a strong database about sites and investigators that can cope with specific project demands We know them.
We talk to them.

Language

We work in a 3-language platform: English, Spanish and Brazilian Portuguese. We are regional and local.
We live and travel here.

WHO WE ARE

CREOS is a company providing solutions in clinical research to the pharmaceutical, biotechnology and medical devices industry in Latin America; always in compliance with GCP and regulations.
MISSION STATEMENT
To contribute to the development of clinical research, based upon education.

To disseminate the methodology of research and the GCP; regulations and directives.

To develop the skills and talents of all those interested in Clinical Research.

To demonstrate that in Clinical Research, a practical solution is always within reach.

Leadership

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.

CREOS co-founder.

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.

Daniel Livio M.D.
President

CREOS co-founder.

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.

Néstor Flaster M.D.
President

CREOS’ upper management is fully involved in all projects

CREOS offers the following capabilities

Tailor-made solutions for each investigation project at each phase and stage in the development of a pharmaceutical, biological or biotechnical product.

Project teams based on client and project needs and on the proper therapeutic and management expertise

OUR VISION: Quality, flexibility and commitment.

CONTACT

For any questions, you can send us an e-mail or contact us directly from this site.
Daniel Livio
+54 9 11 4554 8853
Nestor Flaster
+54 9 11 4553 2525
Giribone 1252, Ciudad de Buenos Aires, C1427CAR, Argentina.