KCE –Application form – KCE-2017_001_CTMSpage 1of8

Application form -
Contract notice: KCE-2017_001_CTMS

Introduction

This form is intended to facilitate the introduction of your application[1].

The information provided below is intended to

-determine whether the application meets the conditions for qualitative selection;

-select the candidates who will receive in a second phase the specifications allowing them to submit a complete offer.

To be eligible, the application must:

-be submitted regularly within the deadline for receipt of applications;[2]

-be signed by the competent person.

The deadline for receipt of applications is Monday 19thJune 2017 at 1PM.

IDENTIFICATION OF CANDIDATE

The company :

Name: / ………………………………………………
Legalform : / ………………………………………………
Nationality : / ………………………………………………
Head office (address): / ………………………………………………
………………………………………………
N° KBO - BCE[3] / ………………………………………………
Website / ………………………………………………

Contact person in charge of this application:

Last name, first name / ………………………………………………
Fonction: / ………………………………………………
Postal address: / ………………………………………………
………………………………………………
………………………………………………
Email:
Telephone :
Mobile: / ………………………………………………
………………………………………………
………………………………………………

ECONOMIC AND FINANCIAL CAPACITY

The average annual sales for the "software as a service"CTMS-type, calculated for the last 3 years, must exceed € 700,000.

Year / Annual sales for the “software as a service” CTMS-type / Currency
2016 / ………… / …………
2015 / ………… / …………
2014 / ………… / …………

TECHNICAL CAPACITY

References

Provide proof of having given access and configured the CTMS software in at least 20 organizations in Europe (an organization that can be a hospital, a funder, a network of hospitals, a funding agency, etc.). This software must be operational, and must manage at least 50 clinical studies in each of the organizations referenced.

For each reference, the tenderer shall indicate

  • the name and address of the organization,
  • the contact details of a contact person,
  • the start date of the implementation,
  • the number of clinical studies in the software for this organization (annual average last 3 years).

The candidate will send 20 references, which must be in line with the services requested.

If the KCE deems it necessary to contact these references, it will inform the candidate in advance.

Doorbuilding · Kruidtuinlaan 55 boulevard du jardinbotanique · Brussel 1000 Bruxelles
T +32 2 287 33 88 · F +32 2 287 33 85 · ·

KCE –Application form – KCE-2017_001_CTMSpage 1of8

# / Name and type of the organisation / Address / Contact person
(name, e-mail) / Start year of implementation / # active studies in software / Additional description (not mandatory)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Doorbuilding · Kruidtuinlaan 55 boulevard du jardinbotanique · Brussel 1000 Bruxelles
T +32 2 287 33 88 · F +32 2 287 33 85 · ·

KCE –Application form – KCE-2017_001_CTMSpage 1of8

Staff employed by the candidate and responsible for the support and maintenance of the requested solution

Please provide:

  • the average annual staff employed by the candidate and in charge of the support and maintenance of the requested solution, during the last 3 years,
  • the number of persons employed by the candidate and in charge of the support and maintenance of the solution requested, for Belgium, at the time of submission of the application. This number must be greater than or equal to 2 persons.

Year / Average annual staff employed by the candidate and in charge of the services requested
Total / For Belgium
2014 / …………………………. / ………………………….
2015 / …………………………. / ………………………….
2016 / …………………………. / ………………………….
At the time of this application / …………………………. / ………………………….

Minimum technical requirements of the IT solution

Present a general description of the company and a basic technical description of the CTMS solution. The following technical specifications are deemed essential by the KCE to be able to submit an offer

  1. It is a "Software as a service" solution that provides an overall view of the status of clinical studies for a recruiting site, for the study sponsor, for the Clinical Trial Center and for the funding agency (the KCE)
  2. Data (and their backups) are stored in a data center located in a European Union country or, failing that, in a country that complies with European data protection legislation (GDPR 2016/679).
  3. Access to the software and the information contained in this software can be configured on the basis of the role of the user, the hospital (site) and the study. A user must first receive access to the data contained in the CTMS before they can modify / delete this data.
  4. The software has a complete audit trail, from each login of each user, for each change made to the data encoded in the software. This audit trail must be available to users with access rights to this data.

(answer maximum 3 pages)

Annexes

Attached as an annex to this application

………………...... ………………………..

Signature

Name / Function
……………………………..
…………………………….. / ……………………………..
……………………………..

Doorbuilding · Kruidtuinlaan 55 boulevard du jardinbotanique · Brussel 1000 Bruxelles
T +32 2 287 33 88 · F +32 2 287 33 85 · ·

[1]The information contained in this form does not supersede those of the contract notice which has sole value as official publication.

[2]The applications can electronically be submitted on the website e-tendering orper post on the address mentioned under point I.1 of the contract notice.

(V_10_05_2017)

[3]Only for Belgian candidates.