News 2020

AICRO-ASSOMONITOR: rSDV and Clinical Research

07/08/2020

AICRO and ASSOMONITOR propose a new approach for Remote Source Data Verification.

Programmatic Document

AIFA: Publishing the guidelines for the collection of the Informed Consent for participation in clinical trials and amendments made to the National Contract

31/07/2020

The National Coordination Centre of Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices, after receiving comments and suggestions from AICRO members CROs, has defined the guidelines for the collection of the Informed Consent necessary for participation in clinical trials.

More information on this LINK

Amendments also made to the Contract for the conduct of clinical trials on medicinal products (Italian/English version).

Information on this is available at this LINK

Publishing by AICRO Scientific Director, Elena Ottavianelli and SIMeF Board Member, Sergio Caroli

SIMeF Newspaper, June 2020

14/07/2020

A focus on biosimilar drugs that aims to question a number of issues related to this type of drug.
Opinions compared by representatives of various public and private bodies.
This and much more is discussed in the June monographic magazine, published by SIMeF

Read more here

The perspective of the CROs on the Italian Clinical Research market and a vision of the current pandemic crisis

9/06/2020

Interview with the President of AICRO, Donato Bonifazi and the coordinator of the Working Group “Communication and Data” Fabrizio Forini at Aboutpharma.

The perspective of the CROs on the Italian Clinical Research market and a vision of the current pandemic crisis. The impact on trials and patient recruitment has been significant. The readiness with which AIFA reacted to speed up the start of studies on Covid-19 suggests the possibility of a more streamlined and efficient system, with less bureaucracy and duplication.

Read more here 

AICRO: New rules for CRA access to experimental centres: AICRO position

28/05/2020

In relation to the request to submit the CRA to procedures to exclude coronavirus infection (SARS-CoV-2) before entering the premises of the clinical centre to carry out a monitoring visit, we point out that AICRO member companies: – as employers, they comply with the legal obligations in force regarding the fight against and containment of the spread of CoViD-19 in the workplace and adopt specific and formal protocols for this purpose; – they are required to monitor the state of health of their employees and, in the event of suspected risk of contagion, to implement all procedures to limit the potential spread of contagion; – they are required to provide their employees with adequate and sufficient Personal Protective Equipment to protect their health and to prevent contagion even during travel. Consequently, AICRO does not believe that CRAs should undergo these tests “on demand” and perhaps frequently, in different centres and with different methods, on which there is uncertainty about the reliability and there is no evidence of how the results and sensitive data of CRAs would be treated. Recalling that the need to visit the centres periodically is a regulatory requirement (sanctioned by GCP-ICH D.M. 15/7/97), as well as a way to guarantee the quality of the experimentations and the safety of the patients, in the interest of the Experimental Centre itself, we consider the precautions already implemented by the CRO associated with AICRO to be sufficient.

Template EN

AIFA: Evaluation of SARS-CoV-2 Infection Studies by Ethics Committees

25/05/2020
The National Coordination Centre of the Ethics Committees has prepared the note “Evaluation of studies on SARS-CoV-2 infection by CE”, with the aim of supporting researchers and Ethics Committees in implementing appropriate pathways for the evaluation by the Ethics Committees of studies on COVID-19.The note refers to the regulatory guidance issued in recent months, including the recent AIFA Circular of 22 May on “Simplified procedures for studies and compassionate uses for emergencies by COVID-19”.

The note is viewable at this Link

AICRO-AIFA: Digitization project of the "RSO - Research Observational Studies"

14/05/2020

AICRO continues its work in collaboration with AIFA for the digitization project of the “NEW OBSERVATIONAL STUDIES REGISTER (RSO)”, launched in July 2019 and aimed at collecting any useful suggestions for the definition of the requirements of the future system. AICRO took part in the design phase by sending its suggestions, consolidated through the comments of the associated CROs, regarding the definition of the requirements of the future RSO system in the clinical trial. AIFA has recently provided timely feedback on the observations made by AICRO. Many expected benefits. Among others: the automation of the management of observational studies through the exchange of documents through a centralized platform, the possibility of generating ad hoc reports and, for the general public, the possibility of access via SPID for consultation. Therefore, having completed the design phase of the computer system by AIFA, AICRO awaits its next involvement in the functional testing/testing phase of the system.

AICRO: Survey 2019 - The status of associated CROs

22/04/2020

AICRO publishes the results of the 2019 survey among member companies. A picture of the state of the art of the CROs in Italy: more than 1000 Clinical Research Associates, 400 Regulatory Affairs and Start Up staff, 300 Project Managers/Clinical Leads, 120 million Euro investment each year, more than 300 studies launched in a year on 2500 experimental centers. A force that has been constantly growing for years and is now a protagonist in applied research.

Summary Survey CRO 2019

AIFA: Emergency Clinical Trials Management Communication COVID-19

7/04/2020
AIFA, with a new communication dated 7 April 2020, provides indications on the management of clinical trials and substantial amendments in Italy following the exceptional restrictive measures introduced by the Italian Government to combat the COVID-19 pandemic (coronavirus disease 19), valid until further notice and closely linked to the state of emergency resolved by the Council of Ministers on 31 January 2020.

EMA: Guide to the management of clinical trials during the COVID-19 pandemic

20/03/2020

The European Medicines Agency (EMA) published today on its website the press release and guidance on the management of clinical trials during the COVID-19 pandemic.

Guide 

Press Relase

FDA: Coronavirus update (COVID-19): FDA issues guidance for conducting clinical trials

18 /03/2020

AICRO informs about the position of the U.S. Food and Drug Administration on the current pandemic.

Relase FDA

Guide document

AIFA: Management of clinical trials in Italy in emergency COVID-19 (coronavirus disease 19)

12/03/2020

The Italian Medicines Agency provides guidance on the management of clinical trials and substantial amendments in Italy during the COVID-19 (coronavirus disease 19) emergency period, valid until further notice.

Official Statement

FADOI: 6th National Conference on Clinical Research - NEW DATES

Following the current emergency and the consequent measures adopted by the Government, the National Conference “Clinical Research and Health Products in the 20s in Italy: analyse prepare, act”, promoted by the Scientific Society of Internal Medicine FADOI, was cancelled. The new dates are 2-4 December 2020.

Official Statement

For more information

IFAPP/SIMeF: ICPM2020 Congress - 1st National SIMeF Conference - POSPONED EVENT

Following the current emergency and the consequent measures adopted by the Government, the IFAPP/SIMeF Congress scheduled for 25-26-27 March 2020 in Rome has been postponed.

Official Statement