This week we thought of sharing a personal insight to one of the countries we are proud to be working since 2013 and decided to incorporate last year, due to its potential.

Our Director of Operations of Russia and Ukraine will answer some of the key questions about site contracting in Ukraine.

1. Presentation of the interviewee

My name is Max. I am acting as General Director of the Russian and Ukrainian branches of CTA Focus. This year I will celebrate my 12th anniversary in site contracts, thus I dedicated all my professional life to this important aspect of clinical trials. Today, I am happy to have this interview dedicated to site contracts process in one of my favourite countries – Ukraine.

I shall admit this interview won’t be this detailed without dedication of my close friends, strong professionals working in the country.

2. Can you share the main challenges in negotiating site contracts in Ukraine, in a few words?

It’s hard to define challenges in a few words. As many of the Eastern European countries, Ukraine has its own specifics.

I believe the main challenge is the Institution contract – difficulties begin when you try to define the contractual party. This can be University based on the Hospital or even vice versa, or both in many cases. And, if we don’t speak about generalities, each Institution has its own internal rules we ultimately need to consider.

Also, we must consider multiple Sub-Investigator agreements per site (average – 4-5 agreements, up to 9 agreements in some cases).

3. Are there any specifics that one must be aware when negotiating contracts in Ukraine?

As mentioned above, we need to focus on Institution agreements. Each institution may have its own process and/or requirements. And in many cases, this is just something we need to accept as they are reluctant to negotiate.

Another important point – country-oriented contract templates. These are utilized by majority of CROs/Sponsors. In case any client has no country-adapted templates for Ukraine, this will cause issues.

4. Are there any contracts particularities, any templates traits or any contracting requirements from Institutions or PIs or any other study team members?

Traditionally Ukraine is quite flexible in terms of contract requirements. But what must be considered – some huge amount of separate Sub-Investigator contracts, medical facility contracts (Lab, Radiology, etc.) – this is simply something the industry must accept.

5. What are the general timelines around site contracts negotiations?

Again, here we need to consider Institution contract as Investigator contract is always faster. From my experience, timeline from beginning of negotiations till full execution may take from 90 to 180 days depending on each particular site. This is why we, the contracts, ask for actual site lists as soon as they are available. We know the sites, thus we can always provide more accurate estimations.

6. What are the budget challenges for Ukrainian sites?

Budget split. It is very often split between multiple study team members. Between university and hospital. It is normal when you have 10-12 payees per site.

Another point to mention – the currency. For PI / sub-Investigator contracts the contract and payment currency can be the same (preferably – EUR or USD), for Institution contracts it is in many cases UAH as institutions mostly cannot accept funds in foreign currency. Consequently, the payee for PI/Sub-I contract shall be foreign entity, but for Institution – it shall in most cases be local one.

7. Are there any site payments specifics that can be taken during site contracts negotiations?

Definitely. As stated above, the amount is always split between multiple payees. Usually it is PI who performs this split, but very often the negotiator jumps in to solve it.

8. Could you share with us an advice on Ukrainian site contracts negotiations?

Ukraine is definitely not a white spot on the map of clinical trials. All Big Pharmas are presented in the country and conduct clinical trials there. Very general advice – listen to the country experts in all the aspects of the clinical trials, including site contracts. Ukraine has a very well-established model of site contracting. Changes are occurring or are expected to occur, for sure, but they are not dramatic and headed to the European integration. Thus, I believe the overall process is predictable and quite transparent. Thus, country knowledge and understanding of the current trends – is all you need for successful negotiations in Ukraine.