News
Cellivery extends global clinical trials of Covid-19 immunotherapy drug ‘iCP-NI’ in India and Europe, signing a contract with OPIS CRO
Recently, Cellivery Therapeutics Inc (268600) announced that it will expand the clinical development of Covid-19 immunotherapy ...
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Quality Management System in OPIS
To ensure quality of performance and data OPIS has established a Quality Management System based on OPIS´ standard operating ...
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Respiratory Diseases
Chronic respiratory diseases (CRDs) are diseases of the airways and other structure of the lung and they are a leading cause of ...
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A new Covid-19 vaccine trial started on the first of March at San Gerardo (Monza, Italy): it’s an Italian vaccine designed by Takis and developed in partnership with Rottapharm Biotech
Takis and Rottapharm Biotech are assessing the safety and immunogenicity of a plasmid-DNA vaccine on healthy adults volunteers. ...
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Orphan Drugs
Rare diseases are diseases which affect a limited number of people. In Europe, a disease is considered rare when it affects no ...
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Pediatric Studies in OPIS
The JAMA Pediatrics journal 2019 reports the increasing prevalence of pediatric chronic disease that has resulted in increased ...
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Targeted and Immune-Based Therapies
Targeted and immune-based therapies have already transformed the standard-of-care for several malignancies. One review article ...
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Artificial intelligence and its application in medicine
Artificial Intelligence is a branch of computer science that deals with the programming and design of both hardware and ...
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World Cancer Day
According to the last IARC World Cancer Report cancer is the first or second leading cause of premature death (i.e. at ages ...
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The Data Privacy Day!
Since the 1960s, tremendous technological development raised questions about privacy protection in the digital world. Millions ...
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The SOLNATIDE Project
PRESS RELEASE New therapeutic peptide solnatide to reduce and alleviate intensive care time for COVID-19 patients ...
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The role of the Clinical Research Associate within a CRO
The Clinical Research Associate (CRA) according to the GCP definition stands for the “person delegated by the Sponsor to ...
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Infectious Diseases
Technological, industrial and biomedical developments have increased life quality and expectancy of the population, resulting ...
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The management of clinical trials in Italy during the COVID-19 spread emergency
During the spread of the Coronavirus pandemic, the monitoring activity at the clinical centers was extensively revised due to ...
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Cardiovascular Diseases (CVDs)
Cardiovascular diseases (CVDs) are a group of disorders of the heart and blood vessels and they include: coronary heart ...
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Rare Diseases
Rare diseases are serious, often chronic diseases that affect a relatively small number of people compared to the general ...
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Study Management in OPIS
OPIS sound experience in clinical trial management and monitoring, and our proficient and well-trained Clinical Operations ...
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The importance of in-company training
The substantial experience in the management of clinical trials which OPIS proves, ensures services set on the highest quality ...
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The Trial Start-Up Specialist’s profile
One of the ascending roles, albeit still little known, in clinical research is that of the Clinical Study Start-Up Specialist. ...
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Medical Affairs in OPIS
The OPIS Medical Affairs Unit is team of experienced people with on average 15 years of experience and professionally qualified ...
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ISO quality standards: a step forward in promoting excellence for our Sponsors
ISO stands for "International Organization for Standardization", an international organization whose task is to define the ...
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The new regulation on medical devices, what and when will it change?
The full application of the new Regulation on Medical Devices (MDR 2017/745) has been postponed to May 26, 2021, also extending ...
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ISO 14155: 2020 Clinical investigation of medical devices for human subjects – Good clinical practice
The international standard ISO / DIS 14155 "Clinical investigation of medical devices for human subjects - Good clinical ...
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OPIS Regulatory Service
A team of experts assist clients with regulatory aspects relating to clinical studies submissions (Phase I-IV, observational), ...
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Real World Evidence: what is it all about?
It is the evidence of the effectiveness and safety of a drug obtained by collecting and analyzing Real World Data (RWD). Real ...
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“Compassionate use”- COVID-19
Compassionate care or compassionate use of a drug represents the possibility of using drugs or therapies for therapeutic ...
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Pharmacovigilance at OPIS
Pharmacovigilance is the set of activities aimed at identifying, evaluating, understanding and preventing adverse effects or ...
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The advantages in partnering with OPIS
OPIS is a full-service Contract Research Organization (CRO) founded in Italy in 1998, providing high quality services for the ...
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OPIS for Nutraceutics
Current Pharmaceutical Biotechnology 2020 presents a review on current prospective of nutraceuticals. ...
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Who is the Data Protection Officer?
The Data Protection Officer (DPO) is a professional figure introduced by the General Data Protection Regulation 2016/679 | GDPR ...
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ePRO: the new patient APP powered by OPIS
Thanks to the work carried out by the ICT unit (Information and Communication Technology), OPIS is always able to be at the ...
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Technological innovation in OPIS
Technology has radically changed our daily life and our existence and the digital revolution has also involved the world of ...
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The importance of the Organization by Process
The world of clinical research represents an ever-growing evolving reality, in which scientific accuracy and cogent regulatory ...
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OPIS for Medical Devices
To date, more than 10.000 medical devices are available on the market and the number corresponding to the amount of medical ...
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Cybersecurity and information security
Cybersecurity and information security are two different terms associated with the security of information systems. ...
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OPIS Pre-Clinical Consultancy
Since OPIS enterprise started off, an impressive amount of effort and dedication has been poured into the great vision of this ...
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COVID-19 – Clinical research and healthcare personnel: thanks from OPIS
Since its founding, OPIS has had the opportunity to collaborate with highly qualified doctors, who with great commitment, ...
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Compassionate use programs – COVID-19 authorized by AIFA
SOLNATIDE, the therapeutic molecule solnatide developed by APEPTICO for the treatment of various forms of life-threatening ...
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Apeptico press release
SOLNATIDE has been approved for the treatment of COVID-19 patients suffering from pulmonary oedema and acute respiratory ...
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OPIS: In the front line in the fight against COVID-19
The spread of Coronavirus continues both in Italy and globally. For this reason, in order to protect the health of its ...
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Reshaping the future of adequate care
The paradigm of treating disease has shifted. Today, we are exploring options where personalized medicines are promising to ...
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The Patient Data Paradigm
Precision medicine and personalised treatment options have become a reality in treating cancer. However, with multiple ...
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Data Managers are worth their weight in gold
The value of experienced data managers is priceless. Please click on the link to read a recently published article by OPIS. ...
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A suited approach to rare disease trials
OPIS is currently involved in a phase II project for an ultra rare disease. Read an interview with Aldo Poli, CEO and trial ...
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