Random II

KPI =

SRM = (and what does it refer to?)

both UC and CD have their primary manifestation in the ___, but in fact CD and UC are ___diseases that can also have other ___, such as ____.

For China study, the team should be located in ___ but do we have PM capability there?

The usual lead time for reg approval in China is __ -- __ months.

In Asia Pac we have PMs located in __ and ___ as well as CTMs in ___, ___ and ___.
One of the Australian PMs has experience managing ___as a country and so do ___ PMs out of EU.
So we would lack __ __of the study there.

Our thinking is that we could offer a competitive price for PRA staff in China especially since we are recruiting additional ___ to add coverage in the country.

For Chian study __ __in the 3 months immediately after ___ __ obtained. Historically, this has been ___ months but recently there have been improvements down to __ months.

For Chian study, Lee wanted to know if they had ___ in place because it takes ages there

C’est valorisant

In Taiwan, CRCs are usually at the __. Please let us know if your CRO has any experience in ___ CRCs to the ___ to support their work if required. Sarah Liao says that PRA __ __ have CRC department like some __ __ to support sites if needed.

PRA’s Taiwan office is staffed with __ clinical research professionals (including __, ___ and ___.

Normally start-up in Taiwan is between __ and __ months.

PRA Taiwan has experience of, and has successfully passed __ inspections __. In a recent inspection the inspector acknowledged PRA’s strong __ __.

PRA has the authority to provide __ representation for UCB in Taiwan

Re legal representation for Taiwan study: UCB may desire for PRA's __ __ __ to act as __ __for the study,

As PRA is legally responsible for ___ in Taiwan, we need to receive an ___ listing on a ___ basis so we can ___ if all SAEs that are expeditable in our opinion have been provided by UCB for expedited ___.

re: legal representation in Taiwan - We will have to have the separate __ __ __ executed by UCB and __ __(after award)

re: legal rep - Since PRA will be responsible for ___ to TFDA and __/__, we will need to build in some __ __/__ __steps to ensure that no ___ was missed.

for legal rep - the additional steps in the process will enable PRA to protect itself from a __ __ perspective

PRA in Taiwan since 2004, so very familiar with the current __ and __ environment. We have executed __ __ __ with most investigative sites in Taiwan which are involved in supporting __ __ __.

For Taiwan, In general, it will take __~__ weeks to get ___ approval,

In order to maximize the time available for sites to __ __and, in turn, to meet __ goals and study timelines. PRA employs __ __ __ __who coordinate every aspect of study __-__.

PRA has a strong presence in the Asia-Pacific (AP) region, with offices in __ countries:

PRA staff in 7 AP countries provide clinical operations coverage for PRA across an additional ___ countries in the region.

We understand the rate limiting factors in obtaining ___ approvals and expediting start-up to allow sites to begin ___ as soon as possible.