2020-2021 have challenged the World with COVID-19 pandemic. This literally concerned everyone and made a huge impact on every sphere of people’s life. Clinical trials are not an exception. The global healthcare system focused on the fight against the coronavirus that required many hospitals switch to COVID-only regime resulting in slow-down of the start-up of clinical trials or even their cancellation.

Lots of clinical trial companies and even some administrative staff of the sites were literally switched to home-based regime of work. Since every crisis is believed to be a combination of ‘danger’ and ‘opportunity’, forced working from home really implies a danger, potential or actual, for a well-established normal way of work as well as an opportunity for the companies to efficiently respond to the pandemic, save business and employees.

It might be too early to judge if the pandemic dramatically increased the trial start-up timing, but it is already clear that this increase is taking place. Clinical trial agreements and budgets negotiation – being traditionally a bottleneck for the fast start-up in many regions – in the current circumstances assumes the greater importance.

According to our polls at CTA Focus, 79% of responders working as contract negotiators in the clinical trial area reported that usual negotiation timelines during the pandemic increased. The increase was described as from ‘sites respond a bit slower’ (53%) to ‘significant delays’ (26%).

Having that in mind and evidencing the visible shift in the clinical trial agreement negotiation process across the world, the industry started to implement the mechanisms on reducing negotiation timeline (such as dealing with the delayed sites’ response), implementing no-contact technologies (such as home-based work, electronic signatures, etc.) aiming to protect the employees and maintaining the business-as-usual approach.

When it comes to the pandemic, the CTA Focus negotiator seems to have very limited capacity to speed up the negotiation process. As was mentioned before, healthcare system in many regions is experiencing extraordinary pressure with a lot of hospitals being converted into COVID-treatment facilities, slowing down or even putting on hold the current clinical trials and/or those that are in the start-up phase.

It doesn’t mean though the negotiator cannot follow-up with the site, but the style of the follow-up should be switched from less asking into more supporting. Be supportive to the sites, and the sites will be supportive in return. This is general rule, however, but it is of upmost importance nowadays. If the site’s non-responsiveness is resulted from the pandemic, it should be totally understood, still the pandemic will go away sooner or later, and the connection with the site cannot be lost.

In addition, the site can slow down due to change of their priorities. Especially large hospitals/institutions often face those ‘agonies of choosing’ – when having a lot of studies on their plate, they have to make difficult decisions which studies are the priority, basing on the site’s technical and staff capacity and the number of the potential patients. It is highly unlikely the site mentions this ‘downgrade of the priority’ to the negotiator, however the negotiator can discuss this with the CRA (Clinical Research Associate) working with this particular site, or check this with the site directly using the best of diplomatic skills.

Communication with the site shall be balanced at all times. Sending short weekly follow-up emails just to have another line in the tracker never leads to the good result. It is no good to call the site every other day knowing the pressure won’t work. Be balanced: supportive, demanding if appropriate, able to take a step back – but always involved.

Final stage of the negotiation – signature process. If before Coronavirus this meant the negotiator performed the hardest part of the job and now should only send the contract to the site and follow-up on signature status, in ‘COVID era’ things became more complicated. Signature as such became impossible in many sites since signatories became not available, logistics became hardly possible or impossible at all.

The industry is responding to this by offering electronic signature of clinical trial agreements. The world is becoming more digital, electronic documents exchange forced many legislations to implement the laws on electronic (digital) signature, such as (e.g., eIDAS in the European Union, NIST-DSS in the USA) long before the pandemic.

The idea of electronic signature is efficient on many levels – it saves time, costs and the planet, by being more environment friendly. Taking into account all the advantages of the electronic signatures, why do we still have to print out contracts and collect wet-ink signatures? Let’s review some reasons:

All or one of the parties don’t have technical infrastructure to sign the contracts electronically. Paradoxically, technology can impact the most technological way of signing contracts. Electronic signature requires specific software, and sometimes devices, that are very often not available at sites. Besides, for example, in traditional countries like Russia it has been impossible to sign electronically using computers that have other operational system than MS Windows.

Gaps in the legislation. In some jurisdictions the legislation on electronic signature, even if it is detailed and clear, simply does not work in practice. The process of signing and recognition of the electronic signature may be so complex and formalised, that it is easier and safer to sign ‘traditionally’, wet ink.

Recognition of signature of the foreign party. This can be an issue if, say, sponsor and site being contract parties belong to different jurisdictions that do not recognise electronic signatures of each other.

Old style approach. Some clinical trial sites, especially in Europe, are just reluctant to upgrade their usual document management processes.

Thus, electronic signature in some regions is still at the stage of ‘some good idea’. Widely used in the North America, it is still a subject of some nonconfidence in Latin America or parts of Europe. It is clear, the countries should pay more attention to this topic as, as pandemic has shown, electronic signature may also be treated as safety measure.

Evidently, after the pandemic turbulence clinical trials management, including the contract negotiation, will never be the same, however it is in the industry’s hands to make it even more technological, safe and creative.

CTA Focus group supports a ´remote twick´ to all aspects pertaining to site contracts and budget negotiation, that could make negotiation more effective for all parties involved.