Dear Colleague,
The purpose of this short presentation is to let you know that we have now a dedicated Division to execute clinical trials in Rosario, Argentina.
CiR (Consultorios Integrados Rosario) is a state of the art facility with 70 doctor offices in which specialists and generalists work every day.
CiRec (CiR Estudios Clinicos) offers GCP-trained coordinators and physicians who have conducted industry-sponsored and ANMAT-approved trials in the past. In addition, we have a steering committee who meets upon demand to tackle issues related to patient recruitment and we have quick access to Ethics Committees.
We know how important rapid patient recruitment is, but in a strict safety environment where data are collected with high quality.
If you have any questions or would like to arrange an official visit for a tour of the facilities please contact me directly.
Many thanks
Guillermo Ortiz
To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-discovering-new-innovations-in-oncology/
Starting off the conversation, Dr. David Bunka will present specific case studies for prostate cancer, multiple myeloma and chronic myelomonocytic leukaemia, highlighting the ability of Optimer technology to deliver novel targeted therapeutics for cancer treatment. Optimer binders are small, highly target specific oligonucleotide-based affinity binders. The Optimer platform offers the ability to develop specific binders targeted to a specific biomarker or to an oncological cell phenotype without the need for known biomarkers. Optimer therapeutics are enabling new strategies in cancer treatment, including the targeted delivery of diverse payloads to cancer cells for precision chemotherapy, or gene therapy approaches.
Dr. Cathie Miller will discuss how archived tissues contain valuable information for clinical research. For over thirty years, BioIVT has worked to expand the characterization of their archived tissues. BioIVT offers complete NGS project management that ensures success. In this presentation, Dr. Miller will review BioIVT’s comprehensive process, their strengths in sample collection through library prep, their in-house and validated partnership capabilities and how BioIVT elevates science.
Finally, Henry Sebesta will introduce KromaTiD’s proprietary technology, Directional Genomic Hybridization™, as an analytical solution for gene & cell therapy oncology treatments. Specifically, Mr. Sebesta will be addressing what Directional Genomic Hybridization is, how it works, and how it can be used to monitor highly important clinical safety metrics including therapeutic vector integration, and genome wide structural rearrangement events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
According to a 2016 Nature survey, more than 70% of researchers have failed to reproduce another scientist’s experiments. To solve the reproducibility problem, the research community demands high-quality biobanks to deliver fit-for-purpose biospecimens – key pillars advancing science in medicine. Precision for Medicine is a global leader in supplying diverse, high quality, IRB-approved, clinically annotated, ready-to-ship human biospecimens.
This talk provides an insider’s look into Precision for Medicine’s variant-rich biobank showcasing biospecimen types, highlighting usage, custom collection solutions and disease-matched control sets across multiple therapeutic areas. Precision for Medicine’s biorepository contains diverse, genetically characterized specimens validated using various NGS assays and platforms.
Described in this talk are just some of the sample types, screening methods, and subsequently the integrated QuartzBio database of variants found. The speakers also discuss Precision for Medicine’s partnership capabilities, such as for supporting companion diagnostic development including inter-laboratory reproducibility, validation kit assembly and prospective collections for matched tissue types, minimal residual disease, and clinical trial enrollment.
Key Topics Include:
- Gain a broad understanding of Precision for Medicine, Biospecimen Solutions variant-rich biobank contents pertaining to different therapeutic areas
- Become familiar with fit-for-purpose human biospecimens, their diverse types and appropriate uses
- Become acquainted with the biospecimen characterization data available from Precision for
Medicine, Biospecimen Solutions
- Discover the various partnership options for sample and patient screening for R&D and CDx development and clinical trial enrollment
To learn more visit:
https://insidescientific.com/webinar/cutting-edge-conversations-discovering-new-innovations-in-oncology/
Starting off the conversation, Dr. David Bunka will present specific case studies for prostate cancer, multiple myeloma and chronic myelomonocytic leukaemia, highlighting the ability of Optimer technology to deliver novel targeted therapeutics for cancer treatment. Optimer binders are small, highly target specific oligonucleotide-based affinity binders. The Optimer platform offers the ability to develop specific binders targeted to a specific biomarker or to an oncological cell phenotype without the need for known biomarkers. Optimer therapeutics are enabling new strategies in cancer treatment, including the targeted delivery of diverse payloads to cancer cells for precision chemotherapy, or gene therapy approaches.
Dr. Cathie Miller will discuss how archived tissues contain valuable information for clinical research. For over thirty years, BioIVT has worked to expand the characterization of their archived tissues. BioIVT offers complete NGS project management that ensures success. In this presentation, Dr. Miller will review BioIVT’s comprehensive process, their strengths in sample collection through library prep, their in-house and validated partnership capabilities and how BioIVT elevates science.
Finally, Henry Sebesta will introduce KromaTiD’s proprietary technology, Directional Genomic Hybridization™, as an analytical solution for gene & cell therapy oncology treatments. Specifically, Mr. Sebesta will be addressing what Directional Genomic Hybridization is, how it works, and how it can be used to monitor highly important clinical safety metrics including therapeutic vector integration, and genome wide structural rearrangement events.
The regulation of biologicals in AustraliaTGA Australia
View this presentation for information on:
* what biologicals are, including classes and current uses
* the Australian biologicals framework
* new and experimental products
* clinical trials and risk management.
According to a 2016 Nature survey, more than 70% of researchers have failed to reproduce another scientist’s experiments. To solve the reproducibility problem, the research community demands high-quality biobanks to deliver fit-for-purpose biospecimens – key pillars advancing science in medicine. Precision for Medicine is a global leader in supplying diverse, high quality, IRB-approved, clinically annotated, ready-to-ship human biospecimens.
This talk provides an insider’s look into Precision for Medicine’s variant-rich biobank showcasing biospecimen types, highlighting usage, custom collection solutions and disease-matched control sets across multiple therapeutic areas. Precision for Medicine’s biorepository contains diverse, genetically characterized specimens validated using various NGS assays and platforms.
Described in this talk are just some of the sample types, screening methods, and subsequently the integrated QuartzBio database of variants found. The speakers also discuss Precision for Medicine’s partnership capabilities, such as for supporting companion diagnostic development including inter-laboratory reproducibility, validation kit assembly and prospective collections for matched tissue types, minimal residual disease, and clinical trial enrollment.
Key Topics Include:
- Gain a broad understanding of Precision for Medicine, Biospecimen Solutions variant-rich biobank contents pertaining to different therapeutic areas
- Become familiar with fit-for-purpose human biospecimens, their diverse types and appropriate uses
- Become acquainted with the biospecimen characterization data available from Precision for
Medicine, Biospecimen Solutions
- Discover the various partnership options for sample and patient screening for R&D and CDx development and clinical trial enrollment
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
Accelerating the translation of medical research - 27 JuneInnovation Agency
Slides from the event focusing on translational research in Liverpool and North of England and why companies are establishing and growing operations in the region.
14th Annual IFATS Meeting November 17-20, 2016 San Diego, California: AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE IN DOGS WITH ARTHROPATIES: SAFETY, FEASIBILITY AND CLINICAL OUTCOME. By Offer Zeira, San Michele Veterinary Hospital
Find out about collaboration and partnership opportunities with the Wellcome Sanger Institute that aims to create exceptional healthcare opportunities for everyone from extraordinary science.
mHealth Israel_Ryo Kosaka_AIST_National Institute of Advanced Industrial Scie...Levi Shapiro
Presentation by Ryo Kosaka, Senior Research Scientist, Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST). Includes an overview of priority strategies in Life Sciences and Biotech and description of the organization of the Life Sciences and Biotech department. Recent projects include a Portable System for High-Speed DNA Quantification, Application of a cell microarray chip for clinical diagnosis and single cell analysis, Safe and Secure Artificial Heart, New diagnosis for liver fibrosis utilizing glycans, AIST ventures from the department of Life Science & Biotech as well as International cooperation.
ReeLabs is a zero debt, presently 10 crore company with a working capital of 100 crores that has recently
ventured into cord blood banking and stem cell research and therapy.
Why to conduct clinical trials in Ukraine? Ukrainian CRODariaAbulova
- Why to conduct clinical trials in Ukraine?
- Who we are - JERELO CRO
- Area of expertise of JERELO
- Cardio surgery case of JERELO CRO
- Stages of MD lifecycle and our facilities for clinical researches on its every stage
- Regulatory services and services of the Authorized Representative in Ukraine
All these issues are described in our presentation.
JERELO is your reliable CRO in Ukraine.
Accelerating the translation of medical research - 27 JuneInnovation Agency
Slides from the event focusing on translational research in Liverpool and North of England and why companies are establishing and growing operations in the region.
14th Annual IFATS Meeting November 17-20, 2016 San Diego, California: AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE IN DOGS WITH ARTHROPATIES: SAFETY, FEASIBILITY AND CLINICAL OUTCOME. By Offer Zeira, San Michele Veterinary Hospital
Find out about collaboration and partnership opportunities with the Wellcome Sanger Institute that aims to create exceptional healthcare opportunities for everyone from extraordinary science.
mHealth Israel_Ryo Kosaka_AIST_National Institute of Advanced Industrial Scie...Levi Shapiro
Presentation by Ryo Kosaka, Senior Research Scientist, Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST). Includes an overview of priority strategies in Life Sciences and Biotech and description of the organization of the Life Sciences and Biotech department. Recent projects include a Portable System for High-Speed DNA Quantification, Application of a cell microarray chip for clinical diagnosis and single cell analysis, Safe and Secure Artificial Heart, New diagnosis for liver fibrosis utilizing glycans, AIST ventures from the department of Life Science & Biotech as well as International cooperation.
ReeLabs is a zero debt, presently 10 crore company with a working capital of 100 crores that has recently
ventured into cord blood banking and stem cell research and therapy.
1. Because your timelines matter and patient recruitment is a global challenge we have created
CiRec
A clinical site dedicated
exclusively to industry-
sponsored trials
1
2. CiRec Background
Location of CiRec
History of trials and ANMAT certifications
Clinical trials dedicated team
Specialties and Patients
Ethics Committee
Advisory Board and Steering Committee
Contact
2
3. CiRec Location
Located in Rosario, the third largest city of Argentina with a population of 1,2 M inhabitants
3
4. Trials at CiRec and ANMAT
• CiRec is the clinical trials unit at CiR a 10-
storey medical building in Rosario
A state of the art intelligent
• CiR is one of the largest ambulatory clinics in building for ambulatory
Rosario with over 100 physicians in 70 offices medicine
and endoscopy suites
• Industry trials conducted under GCP were
originally in the GI space:
• - “A Randomized Double-Blind parallel Study of Rabeprazole
Extended-Release 50mg versus Esomeprazole 40mg for Healing
and symptomatic Relief of Moderate to Severe Erosive
Gastroesophageal Reflux Disease (GERD)” 2008
- “Comparison of the Efficacy and safety of Infliximab,as
Monotherapy or in Combination with Azathioprine, Versus
Azathioprine Monotherapy in Moderate to Severe Active
Ulcerative Colitis (Part 1)
Comparison of maintenance Versus Intermittetnt Infliximab
Treatment in Maintaining remission : A Follow-up of Efficacy
and Safety (Part 2)” 2008
• ANMAT (Argentina’s FDA) certified the site
on : December 2008
• Now CiR has expanded to many other
medical specialties
4
5. CiRec clinical trials team
More than 100 physicians recruit subjects into
protocols
GCP trained study coordinators
Medical Director
Ethics Committee
Dedicated unit with pharmacy, local
laboratories, offices and archives for industry-
sponsored trials
Own SOPs or sponsor SOPs are used
5
7. Ethics Committees
We use an independent external Ethics
Committee :
- CECOR
President: DR. Daniel Sarcuno, MD.
We have our own Ethics Committee that meets
once a week
7
8. Advisory Board and Steering
Committee
Meets on demand
Tackles problems with recruitment and quality
Seasoned industry experienced individuals
All under CDA
Local and International members
8
9. CiRec Contacts
Lic. Guillermo Ortiz, COO
+54 9 341 503 8610
cirec@consultoriosintegrados.org
Dr. Sergio Fuster, Medical Director
0810 7770 CiR (247) int.704
sergio.fuster@consultoriosintegrados.org
Dr. Juana Corte, Study Coordinator
0810 7770 CiR (247) int.705
juanacorte@consultoriosintegrados.org
www.consultoriosintegrados.org
9