Date of dispatch of this notice: 12/11/2015
Expire date: 26/11/2015
External Reference: 2015-865121
TED Reference: 2015/S 221-402863
Prior information notice
Information
Published
Prior information notice
Prior information notice
Classic Sector
Directive 2004/18/EC
Services
Section I: Contracting authority
I.1)
Name, addresses and contact point(s)
National University of Ireland, Galway (NUI Galway)
N/A
University Road
Galway
IE
Contact point(s): Procurement & Contracts Office
For the attention of: Ann Melia
Telephone: +353 91493970
E-mail: tenders@nuigalway.ie
Fax: +353 91494515
N/A
University Road
Galway
IE
Contact point(s): Procurement & Contracts Office
For the attention of: Ann Melia
Telephone: +353 91493970
E-mail: tenders@nuigalway.ie
Fax: +353 91494515
Internet address(es):
General address of the contracting authority/entity: http://www.nuigalway.ie
Address of the buyer profile: http://irl.eu-supply.com/ctm/Supplier/CompanyInformation/Index/414
General address of the contracting authority/entity: http://www.nuigalway.ie
Address of the buyer profile: http://irl.eu-supply.com/ctm/Supplier/CompanyInformation/Index/414
Further information can be obtained from:
The above mentioned contact point(s)
I.2)
Type of the contracting authority
Body governed by public law
I.3)
Main activity
- Education
Section II.B: Object of the contract (Supplies or services)
II.1)
Title attributed to the contract by the contracting authority:
Expressions of Interest - Audit of Procedures and Practices in Regulated Clinical Research
II.2)
Type of contract and place of delivery or of performance
Category No27:
Other services
NUTS code
IRELAND
II.3)
Information on framework agreement
The notice involves the establishment of a framework agreement:
no:
II.4)
Short description of nature and quantity or value of supplies or services:
The purpose of this call for Expression of Interest is to ascertain the marketplace for Audit of Procedures and Practices in Regulated Clinical Research.
Activity 1: Review and assessment of risk mitigation plan for clinical trials conducted in HRB-Clinical Research Facility (NUIG and GUH), where NUIG is the legal Sponsor of such trials. The implementation of a Risk-based Audit Programme for Sponsored Trials is a requirement for NUI Galway. We require the short-term services of an individual/team acutely proficient in the area of clinical trial European and national legislation and associated ICH-GCP guidelines to audit existing activities and provide a knowledge base to confirm/enable adherence to legislation and all applicable regulations, thereby protecting all ongoing and future clinical research activities from the Sponsor point of view. In light of the roll out of the new EU legislation for clinical trials in 2016, it is crucial that the mitigation strategies identified and implemented are future-proofed.
Activity 2: Assessment of the Data Management infrastructure within the HRB-CRFG and implementation of cost-effective and efficient processes in line with current Irish, European and FDA legislation regarding data compliance for clinical data systems and data security and data protection legislation and guidelines.
The successful vendor will undertake an immediate and extensive review of a number of critical areas in clinical research in the HRB-CRFG and will provide recommendations to the Governance teams of NUIG and HSE to ensure compliance as outlined above. The successful vendor will have an inherent understanding of the Irish and European clinical research landscape and will be in a position to undertake this audit immediately on award of contract.
Completed Expression of Interest documents must be emailed to tenders@nuigalway.ie by 10am, Thursday, 26th November 2015.
This contract is divided into lots:
yes
II.5)
Common procurement vocabulary (CPV)
Main vocabulary
73110000
Research services
II.6)
Scheduled date for start of award procedures
26.11.2015
II.7)
Information about Government Procurement Agreement (GPA)
The contract is covered by the Government Procurement Agreement (GPA):
no
II.8)
Additional information:
Information about lots
Title attributed to the contract by the contracting authority:
Lot No: 1
Lot title: Expressions of Interest - Audit of Procedures and Practices in Regulated Clinical Research
1)
Short description:
As described above
2)
Common procurement vocabulary (CPV)
Main vocabulary
73110000
Research services
3)
Quantity or scope:
4)
Indication about different date for start of award procedures and/or duration of contract
5)
Additional information about lots:
Section III: Legal, economic, financial and technical information
Section VI: Complementary information
VI.1)
Information about European Union funds
The contract is related to a project and/or programme financed by European Union funds:
no