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WHAT IS VAT?

VAT is defined as “a value-added tax (VAT) is a consumption tax placed on a product whenever value is added at each stage of the supply chain, from production to the point of sale”

HOW NOT TO GET LOST IN TRANSLATION

Bilingual clinical trial agreements are standard in many non-English speaking countries. Translation from English into local language can be either performed by the negotiator, or this can be outsourced to a certified vendor. In this article we would like to highlight some points a negotiator shall pay attention for while translating or performing translation review.

CLONING CONTRACTS AND BUDGETS: OPTIMIZATION OR ANOTHER CHALLENGE?

Very often when we deal with study extensions, roll-over studies or study programs for the same client, consisting of several similar studies conducted at the same sites, we need to re-negotiate budget and contract terms.

First idea that comes to mind is agreeing with the sites on using similar costs and wording from what was negotiated a few months back, for a similar study of the same client.

START-UP FEE NOT TO SLOW-DOWN SITE INITIATION

Clinical trial sites put quite a lot of time and efforts to initiate a trial – depending on the country, they review trial-related documentation, facilitate preparation of site-specific versions, prepare local ethics / review board submissions, allocate resources for trial-specific trainings, develop site-specific budgets and contracts, etc.

All these pre-initiation activities are the service that shall be paid, even if a trial was not initiated due to sponsor’s decision or regulatory hold off. This study cost is known as Start-up fee.

WHEN INVOICE IS NOT SOMETHING ISSUED BY DEFAULT

Successful contract negotiation and its execution by all parties is very often only the top of the iceberg. Smooth fulfillment of contractual obligations is the most important and lengthy phase of the contract’s lifecycle, and today we would like to speak about contract payments.

According to different surveys site payment delays occur averagely in 40% of cases. Huge percentage, isn’t it? Let’s see how contract negotiator can help to tackle this issue.

It looks simple – site performs work and invoices this to the sponsor (or designee) as frequently as agreed in the contract, the sponsor performs payment within contractually agreed term.

But is it so easy to get site’s invoice? In many cases it is not. Though it looks like the site is interested in being paid more than anyone else, paradoxically it may take some efforts for the sponsor to be invoiced.

Country and site-specific processes may complicate the process.