News & Events

News

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 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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Events

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