Hysbysiad contract
Adran I:
Endid
contractio
I.1) Enw a chyfeiriad
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital, Freeman Road, High Heaton
Newcastle-upon-Tyne
NE7 7DN
UK
Person cyswllt: Ewan Bond
Ffôn: +44 1912138916
E-bost: ewan.bond@nhs.net
NUTS: UKC22
Cyfeiriad(au) rhyngrwyd
Prif gyfeiriad: https://www.newcastle-hospitals.nhs.uk
Cyfeiriad proffil y prynwr: https://www.newcastle-hospitals.nhs.uk
I.3) Cyfathrebu
Mae'r dogfennau caffael ar gael ar gyfer mynediad uniongyrchol anghyfyngedig a llawn, yn rhad ac am ddim ar:
https://health-family.force.com/s/Welcome
Gellir cael gwybodaeth ychwanegol o'r cyfeiriad uchod
Rhaid anfon tendrau neu geisiadau i gymryd rhan yn electronig at:
https://health-family.force.com/s/Welcome
Rhaid anfon tendrau neu geisiadau i gymryd rhan i'r cyfeiriad uchod:
Mae cyfathrebu electronig yn gofyn am ddefnyddio offer a dyfeisiau nad ydynt ar gael yn gyffredinol. Mae mynediad uniongyrchol anghyfgyfyngiedig a llawn i'r offer a dyfeisiau hyn yn bosibl, yn rhad ac am ddim, yn:
https://health-family.force.com/s/Welcome
I.4) Y math o awdurdod contractio
Corff a lywodraethir gan gyfraith gyhoeddus
I.5) Prif weithgaredd
Iechyd
Adran II: Gwrthrych
II.1) Cwmpas y caffaeliad
II.1.1) Teitl
Digital Site File Application
II.1.2) Prif god CPV
48000000
II.1.3) Y math o gontract
Cyflenwadau
II.1.4) Disgrifiad byr
The Clinical Research Directorate of the Newcastle upon Tyne NHS Foundation Trust currently maintains a large number of paper site files relating to study governance. Each site file contains documents such as study protocols, ethics regulatory approvals, delegation logs, training logs, consent forms and email correspondence. Each study will have between three and ten large lever arch site files and there are currently 1,400 studies in progress.<br/><br/>Many of the above documents are dynamic and version-controlled and paper copies of all changes must be retained for audit purposes. After study closure the files are sent to an off-site storage facility for periods ranging from five to 25 years depending on the nature of the study.<br/><br/>The Directorate wishes to implement a fully electronic site file for each study that will vastly reduce the use of paper documents, reduce the amount of staff time spent on printing and filing and eliminate the requirement to use an off-site storage facility to archive the documents of studies that have closed.<br/>The system must have the facility to:<br/><br/>a. Store and version-control documents<br/>b. Allow electronic signature of documents<br/>c. Be accessed and viewed remotely by non-trust employees with appropriate access controls <br/>d. Be aligned with Good Clinical Practice (GCP) expectations around controls, security, training and validation (Section 10.5.3 in the Grey Guide)<br/>e. Comply with Medicines & Healthcare products Regulatory Agency (MRHA) regulatory requirements<br/>f. Create an audit trail for all activities in the system.<br/>g. Create a comprehensive folder structure with sub-folders to facilitate storage and easy retrieval of documents<br/>h. Be configurable to organisational requirements<br/>j. Have search functionality for the location of documents with multiple options including pdf <br/>j. Exchange regulatory and source documentation with Sponsor/CTU<br/>k. Manage study timelines via alerts e.g. submission of annual reports<br/>l. Manage “live documents” e.g. amendment logs, delegation logs, AE/SAE logs
II.1.6) Gwybodaeth am lotiau
Mae’r contract hwn wedi’i rannu’n lotiau:
Na
II.2) Disgrifiad
II.2.3) Man cyflawni
Cod NUTS:
UKC22
Prif safle neu fan cyflawni:
NE3 3HD
II.2.4) Disgrifiad o’r caffaeliad
To procure a Digital Site File
II.2.5) Meini prawf dyfarnu
Maen prawf isod:
Maes prawf ansawdd: Social Value
/ Pwysoliad: 10
Maes prawf ansawdd: Specification
/ Pwysoliad: 70
Maen prawf cost: Commercial
/ Pwysoliad: 20
II.2.7) Hyd y contract, y cytundeb fframwaith neu’r system brynu ddynamig
Hyd mewn misoedd: 60
Gall y contract hwn gael ei adnewyddu: Na
II.2.9) Gwybodaeth am y cyfyngiadau ar nifer yr ymgeiswyr a gaiff eu gwahodd
II.2.10) Gwybodaeth am amrywiadau
Derbynnir amrywiadau:
Na
II.2.11) Gwybodaeth am opsiynau
Opsiynau:
Na
II.2.13) Gwybodaeth am Gronfeydd yr Undeb Ewropeaidd
Mae'r broses gaffael yn gysylltiedig â phrosiect a/neu raglen a ariennir gan gronfeydd yr Undeb Ewropeaidd:
Na
Section IV: Gweithdrefn
IV.1) Disgrifiad
IV.1.1) Y math o weithdrefn
Gweithdrefn agored
IV.1.8) Gwybodaeth am Gytundeb Caffael y Llywodraeth (GPA)
The procurement is covered by the Government Procurement Agreement:
Na
IV.2) Gwybodaeth weinyddol
IV.2.2) Terfyn amser i dendrau neu geisiadau i gymryd rhan ddod i law
Dyddiad:
10/11/2023
Amser lleol: 17:00
IV.2.4) Ym mha iaith/ieithoedd y gellir cyflwyno tendrau neu geisiadau i gymryd rhan
EN
IV.2.6) Yr isafswm cyfnod gofynnol i’r sawl sy’n tendro gynnal y tendr
Rhaid i’r tendr fod yn ddilys tan:
28/02/2024
IV.2.7) Amodau ar gyfer agor tendrau
Dyddiad:
09/10/2023
Amser lleol: 14:00
Section VI: Gwybodaeth ategol
VI.1) Gwybodaeth am ailddigwydd
Caffaeliad cylchol yw hwn:
Ydy
Amseriad amcangyfrifedig ar gyfer cyhoeddi hysbysiadau pellach:
January 2028
VI.4) Gweithdrefnau adolygu
VI.4.1) Corff adolygu
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Regent Point
NEWCASTLE UPON TYNE
NE7 7DN
UK
E-bost: procurement@noecpc.nhs.uk
Cyfeiriad(au) rhyngrwyd
URL: https://www.noecpc.nhs.uk
VI.5) Dyddiad anfon yr hysbysiad hwn
09/10/2023