LOCAL ETHICS AND SITE CONTRACTS: OPEN RELATONSHIP OR COMMITMENT?

Local Ethic Committees (LECs) and their approach to Site Contracts/Budgets is another point of interest for the Contract Negotiator.

Some of the public sites participating in clinical trials, usually university hospitals, have their own process of vetting a clinical study. They analyse the study documentation, including contract and budget proposals in internal Ethics Committees. These ECs meet once or twice per month and they review pre-required documentation in order to approve the study for the sites selected for participation already by the Sponsor or Sponsor’s designee.

HOW TO STOP BEING AFRAID OF TRACKERS

Following our article on negotiation timelines projection, we decided to touch another point that is usually sensitive to our contract negotiators, and consequently, to their managers, consequently, to the overall clinical trial teams.

This is Contract Negotiation Trackers.

NEGOTIATION TIMELINES PROJECTION: GUESS-WORK OR PROFESSIONALISM?

One of the challenges a contract negotiator faces day-by-day is the projection of negotiation timelines. The need to make proper projection is not just a whim of a Client, but a very important point that is taken into account while planning the overall clinical trial, since no clinical trial site can start the trial without fully executed clinical trial agreements.

Projection is always a challenge. The contract negotiator shall consider quite a lot of factors while projecting the timelines. In this article we would like to cover some of these factors:

SITE’S LIABILITY INSURANCE IS NOT SITE’S BUSINESS?

Couple of weeks ago we discussed how non-negotiability can be tackled during site budget negotiation. This time we would like to talk about CTA wording, namely covering insurance in Eastern Europe, in particular Russia and Ukraine.

In both countries there is a legal requirement to arrange for insurance of the subjects’ life and health. If Sponsor doesn’t provide this kind of insurance, the study cannot even be submitted to the regulatory authorities for approval.

To CALL or to EMAIL, that is the Question

X is a contract negotiator. He received final approved Clinical Trial Agreement (CTA) and budget templates and emailed them to a site for their first review. In a week, X didn’t receive any feedback from the site and sent another follow-up email. Another week has gone and still no news from the site, X emails another reminder. The project management is concerned on the lack of response but sees in the tracker that weekly follow-up is performed by X, so seems it is all stuck with the site.

‘NON-NEGOTIABLE’ AS THE SUBJECT OF NEGOTIATION

How often do we hear ‘This is non-negotiable’ when you negotiate a budget with a site? Surely, quite often. If it is about site-specific or additional out-of-budget fee, negotiator will surely seek for client’s approval.

But what stands for ‘non-negotiable’ in reality and how to tackle the non-negotiability?

Local Contracts Negotiator – Global Sense (?)

A professional who has the best knowledge of local laws and practices, who can harmonize needs and interests of multiple parties, turn ‘no’ into ‘yes’, a person who is very often between hammer and anvil – all these statements can perfectly describe a contract negotiator’s role.

‘ANCILLARY’ DOESN’T MEAN ‘LESS IMPORTANT’

Clinical Trial Agreements (CTAs) are very often accompanied by Ancillary Agreements to cover services which are required by Protocol, but - by various reasons - neither Institutions nor Investigators cannot provide them under regular CTAs.

It is a wide spread practice when a negotiator focuses strictly on CTAs thinking that Ancillary Agreements are something that can be dealt with later. And very often such approach leads to undesirable consequences.

Interview about site contracting in Ukraine

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.

Investigator Payments in Russia: Dotting the “i”

This article concerns the legitimacy of contracts concluded between clinical trial investigators and sponsors (or sponsors’ designees), that seems to be an ongoing concern in Russia.