News
MDR: It’s Not the End of the World for Medtech Companies
February, 2020
The new MDR heralds the beginning of a more regulated era in the medical device industry and with that come concerns about the requirements and costs that it imposes. Chief among the many potential consequences is that US and European medtechs may no longer look to Europe first to get CE mark and begin commercialization. But MDR doesn’t have to strike fear in the hearts and minds of medtech executives. Here are proven tools that companies can employ in order to ensure a smoother and less costly transition to the new MDR system.
The new MDR heralds the beginning of a more regulated era in the medical device industry and with that come concerns about the requirements and costs that it imposes. Chief among the many potential consequences is that US and European medtechs may no longer look to Europe first to get CE mark and begin commercialization. But MDR doesn’t have to strike fear in the hearts and minds of medtech executives. Here are proven tools that companies can employ in order to ensure a smoother and less costly transition to the new MDR system.
StatisticaMedica receives EU investment to support the BreathSpec project
May, 2017
StatisticaMedica receives EU investment to support the BreathSpec project a new exciting trial that aims to develop a rapid, non-invasive device for the diagnosis of respiratory illnesses.
StatisticaMedica receives EU investment to support the BreathSpec project a new exciting trial that aims to develop a rapid, non-invasive device for the diagnosis of respiratory illnesses.
Clinical Research for Non-Clinical researcher - IPPOSI IPPOSI on Twitter:
December, 2016
December 2016. Clinical Research for Non-Clinical researcher - IPPOSI IPPOSI on Twitter: "The inimitable Gloria Crispino talks statics without maths. 1. The inimitable Gloria Crispino talks statics without maths #IPPOSIpic.twitter.com/UXfMab1VRF. 3:06 AM - 9 Dec 2015. 2 Likes; Gloria Crispino Richard ..
December 2016. Clinical Research for Non-Clinical researcher - IPPOSI IPPOSI on Twitter: "The inimitable Gloria Crispino talks statics without maths. 1. The inimitable Gloria Crispino talks statics without maths #IPPOSIpic.twitter.com/UXfMab1VRF. 3:06 AM - 9 Dec 2015. 2 Likes; Gloria Crispino Richard ..
New articles in paediatrics and respiratory diseases
October, 2015
New articles in paediatrics and respiratory diseases have been published by Gloria Crispino, CEO of StatisticaMedica, as a co-author.
New articles in paediatrics and respiratory diseases have been published by Gloria Crispino, CEO of StatisticaMedica, as a co-author.
StatisticaMedica hosts visiting Professor, Omayra Ortega
September, 2014
StatisticaMedica hosts visiting Professor, Omayra Ortega, Epidemiologist at Arizona State University, ASU , to collaborate on the NACDA children study.
StatisticaMedica hosts visiting Professor, Omayra Ortega, Epidemiologist at Arizona State University, ASU , to collaborate on the NACDA children study.
StatisticaMedica A Catalyst forMedical Breakthroughs
December, 2018
When it comes to the world of medical research and development, three major aspects play a crucial role in its success: time to market, low costs, and the effectiveness of the end product. Where there is absolutely no room for error, the only way to ensure favorable outcomes is by knowing the answers to the toughest questions
When it comes to the world of medical research and development, three major aspects play a crucial role in its success: time to market, low costs, and the effectiveness of the end product. Where there is absolutely no room for error, the only way to ensure favorable outcomes is by knowing the answers to the toughest questions
StatisticaMedica’s office in Milan is expanding
April, 2017
StatisticaMedica’s office in Milan is expanding. We have now 2 biostatisticians and 2 IT developers that support the data collection and data analysis of our international clinical trials.
StatisticaMedica’s office in Milan is expanding. We have now 2 biostatisticians and 2 IT developers that support the data collection and data analysis of our international clinical trials.
StatisticaMedica wins its first proposal to support drone research in health
February, 2017
StatisticaMedica wins its first proposal to support drone research in health. We are supporting RTI in the design, data collection and data analysis of one of their first studies to use drone maps to identify potential Zika and malaria breeding sites to optimize the eradication process in Guatemala.
StatisticaMedica wins its first proposal to support drone research in health. We are supporting RTI in the design, data collection and data analysis of one of their first studies to use drone maps to identify potential Zika and malaria breeding sites to optimize the eradication process in Guatemala.
Among thousands of Annals articles downloaded from ScienceDirect each year
February, 2016
Among thousands of Annals articles downloaded from ScienceDirect each year, the Cronin J et al. Paediatric Asthma study of which StatisticaMedica is a co-investigator generates top interest. From October-December 2015The full text of the article, " A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department,” was among the top 5 downloads.
Among thousands of Annals articles downloaded from ScienceDirect each year, the Cronin J et al. Paediatric Asthma study of which StatisticaMedica is a co-investigator generates top interest. From October-December 2015The full text of the article, " A Randomized Trial of Single-Dose Oral Dexamethasone Versus Multidose Prednisolone for Acute Exacerbations of Asthma in Children Who Attend the Emergency Department,” was among the top 5 downloads.
Dr. Gloria Crispino appointed Adjunct Professor at MTBI
July, 2014
Dr. Gloria Crispino appointed Adjunct Professor at MTBI, the Mathematical and Theoretical Biology Institute at the Simon A. Levin Mathematical, Computational and Modeling Sciences Centre at Arizona State University, USA.
Dr. Gloria Crispino appointed Adjunct Professor at MTBI, the Mathematical and Theoretical Biology Institute at the Simon A. Levin Mathematical, Computational and Modeling Sciences Centre at Arizona State University, USA.
StatisticaMedica starts their 100th project! From a small start-up to an international player.
May, 2018
StatisticaMedica started to operate at the end of 2012 with FDA studies for the reclassification of the new generation of AEDs – defibrillators with real time feedback. We grew since then to include several studies for both medical devices and medicinal products, in the US and the EU jurisdictions. In May 2018 we reached our 100th Project. Of these projects, 40% are with medical devices, 36% with drugs, 14% in nutrition and 10% in healthcare. 55% of our studies are FDA-grade or equivalent.
StatisticaMedica started to operate at the end of 2012 with FDA studies for the reclassification of the new generation of AEDs – defibrillators with real time feedback. We grew since then to include several studies for both medical devices and medicinal products, in the US and the EU jurisdictions. In May 2018 we reached our 100th Project. Of these projects, 40% are with medical devices, 36% with drugs, 14% in nutrition and 10% in healthcare. 55% of our studies are FDA-grade or equivalent.
StatisticaMedica continues to grow their expertise in trials that develop treatments in Urogenital Disorders
March, 2017
StatisticaMedica continues to grow their expertise in trials that develop treatments in Urogenital Disorders. We are excited to work with Ixaltis SA, a leader in experimental research and development of innovative compounds. We are supporting their first Phase II clinical study on Litoxetine.
StatisticaMedica continues to grow their expertise in trials that develop treatments in Urogenital Disorders. We are excited to work with Ixaltis SA, a leader in experimental research and development of innovative compounds. We are supporting their first Phase II clinical study on Litoxetine.
Prof. Gloria Crispino is presenting at the RTI-UVG Drone Research Conference at the Universidad del Valle de Guatemala in Guatemala City, Guatemala, on April 20-21 2016
April, 2016
The conference explores the research applications of unmanned aerial vehicles (drones). Prof. Crispino’s presentation focuses on the similarities between the clinical development plan for medical devices and the drone research development plan for application in health and security.
The conference explores the research applications of unmanned aerial vehicles (drones). Prof. Crispino’s presentation focuses on the similarities between the clinical development plan for medical devices and the drone research development plan for application in health and security.
StatisticaMedica opens its mainland European office in Milan
May, 2015
StatisticaMedica opens its mainland European office in Milan, Italy, in partnership with Nunatac , a large Business Intelligence and Statistical consultancy company. Currently providing statistical analysis for clinical trials in Northern Italy.
StatisticaMedica opens its mainland European office in Milan, Italy, in partnership with Nunatac , a large Business Intelligence and Statistical consultancy company. Currently providing statistical analysis for clinical trials in Northern Italy.
We speak the same language - ” StatisticaMedica is now a Member of CDISC
January, 2018
We speak the same language.” StatisticaMedica is now a Member of CDISC. StatisticaMedica continues to grow and expand its infrastructure. Standards have just got higher – StatisticaMedica is now a Member of CDISC. We offer fully compliant ADAM and SDTM packages as part of our Statistics and Data Management services.
We speak the same language.” StatisticaMedica is now a Member of CDISC. StatisticaMedica continues to grow and expand its infrastructure. Standards have just got higher – StatisticaMedica is now a Member of CDISC. We offer fully compliant ADAM and SDTM packages as part of our Statistics and Data Management services.
Highway to the Dexamethasone – For Pediatric Asthma Exacerbations
November, 2017
Highway to the Dexamethasone – For Pediatric Asthma Exacerbations. Asthma research conducted at StatisticaMedica continues to receive excellent reviews. Read the latest news.
Highway to the Dexamethasone – For Pediatric Asthma Exacerbations. Asthma research conducted at StatisticaMedica continues to receive excellent reviews. Read the latest news.
Gloria Crispino, CEO of StatisticaMedica, is appointed Professor of Biostatistics at the Royal College of Surgeons of Ireland
March. 2016
Gloria Crispino will join the Division of Population Health Science as Associate Professor of Biostatistics and Director of the new Biostatistics Unit at RCSI. Her role will focus on biostatistics research in the field of clinical research and epidemiology. Gloria will lead the new biostatistics unit to support health research within RCSI in Ireland and internationally.
Gloria Crispino will join the Division of Population Health Science as Associate Professor of Biostatistics and Director of the new Biostatistics Unit at RCSI. Her role will focus on biostatistics research in the field of clinical research and epidemiology. Gloria will lead the new biostatistics unit to support health research within RCSI in Ireland and internationally.
StatisticaMedica is awarded the NACDA National Children Study
September, 2014
StatisticaMedica is awarded the NACDA National Children Study - the first national study to estimate the prevalence of children of or living with parental substance misuse in Ireland.
StatisticaMedica is awarded the NACDA National Children Study - the first national study to estimate the prevalence of children of or living with parental substance misuse in Ireland.
Book Launch: Quantitative Health Research: Issues and Methods
October, 2013
Book Launch: Quantitative Health Research: Issues and Methods. Gloria Crispino, CEO of StatisticaMedica, author of Chapter 9: Sampling Issues in Health Care Research.
Book Launch: Quantitative Health Research: Issues and Methods. Gloria Crispino, CEO of StatisticaMedica, author of Chapter 9: Sampling Issues in Health Care Research.