eCONSENT and clinical trials

Clinical research is possible because patient volunteers give their consent to participate in trials. Informed consent is a key part of enrolling patients in a clinical trial whereby the potential participant receives all the information they need about their role in the clinical trial. 

It is a central part of ICH GCP that informed consent should be freely given

It is a legal requirement for all clinical trials and does not simply involve signing a sheet of paper, it involves patients asking questions and speaking with their physician so that they fully understand what is involved.

Moving from paper to digital 

While in the past consent was acquired through a traditional pen and paper approach, more recently there has been a growing trend towards electronic consent – eCONSENT.  Just like the regular paper-based consent eCONSENT is not merely getting a digital signature. It uses multimedia elements which can be used to develop an interactive and engaging informed consent experience for patient volunteers. 


According to the not-for-profit organization TransCelerate, eCONSENT has the potential to improve communications between site staff and patients as well as offering opportunities for greater patient engagement. Proponents of eCONSENT argue that as clinical trials have become increasingly complex so too have consent forms. 

Traditional means of gaining consent don’t always cater for varying degrees of literacy and health literacy among patient volunteers. By using alternative media like video, audio and infographics patients may gain better understanding of their participation in clinical trials. Consider for example a clinical trial involving patients with dementia, eCONSENT can offer flexibility in terms of how patient information is presented through multimedia materials tailored to these patients cognitive and communication abilities. eCONSENT also offers a fully traceable digital record of the consent process which will help sponsors with regulatory inspections.

Potential advantages:

  • improving understanding among patients;
  • testing and reinforcing participant understanding;
  • providing valuable feedback on how consent materials could be improved ;
  • improving patient recruitment process and retention;
  • enabling process efficiencies, saving time and money.


However, some concerns remain about the adoption of this digital approach to consent including issues relating to software standardization, the IT investment required, cybersecurity and data privacy.

The future 

 While eCONSENT technology has been around for some time the clinical trials sector has been slow to adopt it, preferring to stick with traditional models. However, the COVID-19 pandemic has brought eCONSENT back into the spotlight as CROs and sponsors were forced to rapidly adapt their clinical research models in line with public health restrictions. As the industry pivoted to decentralized trials and remote monitoring eCONSENT has emerged as a major trend that looks set to become firmly established in the years ahead.

 Learn more about the regulatory framework around eConsent:

FDA Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers


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“The establishment of the Poland office is a major development in line with Cromos Pharma’s continued expansion in European and US operations marking another milestone in the sustained growth of the Company. Poland is a significant clinical trials market that has many advantages making it highly attractive to international sponsors,” said Dr. Vlad Bogin, CEO, Cromos Pharma, “Cromos Pharma looks forward to offering sponsors an extended range of our expert services through its new office to ensure effective and cost-efficient execution of clinical trials”.

With its 40 million people Poland is one of the largest clinical trials markets in Eastern Europe that has a strong track record of over 20 years in delivering high-quality research. It boasts several advantages including a large naïve population and well-developed research infrastructure. Polish patients are positively disposed to taking part in clinical trials as it offers them an opportunity to access innovative treatments otherwise not always available to them. The country has a large network of highly skilled and motivated clinical investigators and medical professionals keen to participate in clinical research. Poland also offers relatively low costs and excellent patient recruitment.

With excellent rates of patient recruitment, high-quality data, highly skilled and committed investigators, and comparatively low costs, Poland is an attractive location for sponsors. Cromos Pharma is ready to help you access these advantages through our excellent knowledge of the regulatory processes and our existing relationships with sites and investigators.

Learn more about conducting clinical trials in Poland with Cromos Pharma here.

To explore these advantages and the services Cromos Pharma can offer you please email

About Cromos Pharma

Cromos Pharma is an international Contract Research Organization (CRO) providing tailored and effective clinical trials management to support the development of drugs that transform healthcare. It offers fully integrated services with expertise in all aspects of clinical trials of all phases in a wide range of therapeutic indications. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has an extensive network of offices across 15 countries and strong regional experience in Central and Eastern Europe. Its European HQ is situated in Dublin, Ireland and its US base is in Portland, Oregon with an operational base in South Florida.

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