Expression of Interest (EOI) for of Interest... · 2020-01-24 · Page 3 of 18 1. NOTICE INVITING...

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CLINICAL DEVELOPMENT SERVICES AGENCY

(An extramural unit of Translational Health Science and Technology Institute An autonomous Institute of the Dept. of Biotechnology, Ministry of Science &

Technology, Govt. of India) NCR-Biotech Science cluster,

3rd Floor, Translational Health Science and Technology Institute building Third milestone, Gurugram - Faridabad Expressway,

Faridabad -121001 Phone: +91-129-2876455

Expression of Interest (EOI) for

Procurement of Clinical Data Management System (CDMS)/ EDC (Electronic Data

Capture) tool to capture the clinical study data in electronic format at

Clinical Development Services Agency (CDSA),

THSTI, NCR Biotech Science Cluster, Faridabad

(EOI No.: CDSA/EOI/ 01/2019-20)

22th April 2019

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Table of Contents 1. NOTICE INVITING EOI ................................................................................................................................................. 3

2. DATA SHEET / TIME LINES .......................................................................................................................................... 4

3. INTRODUCTION .......................................................................................................................................................... 5

4. SCOPE OF WORK ........................................................................................................................................................ 5

5. SUBMISSION OF THE EOI ........................................................................................................................................... 6

6. ELIGIBILITY CRITERIA .................................................................................................................................................. 7

7. EVALUATION METHODOLOGY ................................................................................................................................... 9

8. TERMS OF REFERENCE ............................................................................................................................................. 11

9. APPLICATION FORM ................................................................................................................................................. 12

10. INSTRUCTIONS FOR ONLINE SUBMISSION .............................................................................................................. 16

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1. NOTICE INVITING EOI

Ref. No. EOI No.: CDSA/EOI/ 01/2019-20 Date: 22/04/2019

On behalf of the Program Director, Clinical Development Services Agency (CDSA), an extramural unit of

Translational Health Science and Technology Institute Faridabad, Haryana, INDIA sealed Expression of Interest herein after referred to as EOI is being invited from eligible and interested firms for the supply of the following item(s): -

Title of the work/service(s) Cost of EOI Document

Clinical Data Management System (CDMS)/ EDC (Electronic

Data Capture) tool to capture the clinical study data in

electronic format

Rs. 2000

The complete set of Expression of Interest document may be downloaded from CPP Portal

www.eprocure.gov.in. and our website: http://thsti.res.in/cdsa/ (for reference). Cost of tender

documents Rs.2000 (Non-refundable) should be payable by Demand Draft or Pay Order issued

by scheduled bank in favour of “CLINICAL DEVELOPMENT SERVICES AGENCY” payable at Gurgaon

Haryana. The original DD/PO should be submitted to CDSA on or before the last date of

submission of EoI.

To solicit prospective bidders’ feedback, on specifications/terms of the EOI, a pre-EOI meeting with all the prospective bidders is scheduled to be held on 29/04/2019 at 2:00 PM. The venue of the meeting will be CLINICAL DEVELOPMENT SERVICES AGENCY, Faridabad. Interested firms are invited to attend the same with a written statement of their queries. All future corrigendum/amendments etc., if any, will be notified only on the http://thsti.res.in/cdsa/ website and no separate advertisement will be released for the same. Prospective bidders are therefore advised to regularly visit the http://thsti.res.in/cdsa/ website for any such updates.

Admin and Finance Manager, CDSA

http://www.eprocure.gov.in/

http://thsti.res.in/cdsa/

http://thsti.res.in/cdsa/

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2. DATA SHEET / TIME LINES

The critical data sheet/time lines is as follows:

S.No Particulars Date Time

1. Document No: CDSA/EOI/ 01/2019-20 ….. …..

2. Name of the Work: Procurement of Clinical Data

Management System or EDC tool to capture

study data in electronic format.

….. …..

3. Brief Scope of Work: A validated and 21 CFR

part11 complaint Clinical Data Management

system/ EDC tool which is required to capture the

study data electronically into the system.

….. …..

4. Estimated Cost of the Project: Rs. 30 Lakhs ….. …..

5. Non-refundable cost of EoI document: Rs.2000 ….. …..

6. Publishing date 22/04/2019 16.00 hrs

7. EOI Document available for download 22/04/2019 16.00 hrs

8. Pre-EOI meeting/ Meeting for clarifications on EoI 29/04/2019 14.00 hrs

9. Minutes of the meeting on clarification and revised

EoI documents (if required) to be uploaded on E -

portal

30/04/2019 15.00 hrs

10. EoI submission Start date 01/05/2019 15.00 hrs

11. EoI submission End date 13/05/2019 15.00 hrs

12. EoI Opening date 14/05/2019 15.00 hrs

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3. INTRODUCTION

Clinical Development Services Agency is an extramural unit of Translational Health Science and

Technology Institute, an autonomous Institute of the Department of Biotechnology, Ministry of

Science and Technology, Govt. of India.

It was created to facilitate development of affordable healthcare products for public health

diseases. Registered as a not-for profit research organization, it aims to develop an eco-system

for training and learning and work with public sector institutions, and small and medium

enterprises (SME) to translate innovative technologies into medical products for public good.

Currently, CDSA is looking for companies who have expertise in providing electronically managed

Clinical Data Management Systems (CDMS) and have past experience in managing the clinical

trial databases. The hiring company has to provide the validated CDMS, Hosting Solutions and

should have the capability of integration with other systems like Clinical Trial Monitoring System

(CTMS), Lab management system & Bio-repository systems for the duration of minimum 36

months and likely to be continued thereafter. The CDMS will be installed in placed in secured

server with dedicated space. The company has to provide training, support and maintenance

throughout the contract period

4. SCOPE OF WORK

Considering the increasing quantum of studies, CDSA is looking for the procurement of the CDMS

or EDC (Electronic Data Capture) tool. The system should have but not limited to the following:

1. 21 CFR (Code of Federal Regulation) Part11 & CDISC (Clinical Data Interchange

Standard Consortium) standards complaint

2. Multiple and multicentre studies

3. User Creation

4. Edit checks, range checks, logic checks etc.

5. Discrepancy management including report generation

6. External data load i.e. import lab data etc.

7. Job scheduler (Automated alerts/notifications)

8. Study documents repository

9. Reports (excel/csv/SAS/pdf/word)

10. Study Data Tabulation Model (SDTM) Export

11. Dashboard for management, study and site level

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12. Report extraction (standard and customized) at management, study, site and

patient level for various users and levels

13. Integration with other tools such as IVRS (Interactive Voice Response System), IWRS

(Interactive Web Response System), Lab normalization, Imaging, Biorepository,

Barcode scanner, CTMS (Clinical Trial Management System) etc.

14. Audit trail

15. Real time data synchronization

16. Offline mode (automatic synchronization in the range of internet)

17. Compatible with tablet, mobile & iPad

18. Compatible with various OS – android etc.

19. Regulatory Requirements (Administrative/ User roles, Protocol Amendments,

Password Management & Audit Trail)

Along with CDMS, bidder should provide:

1. System validation documents & User manual

2. Installation, configuration & setup of the system

3. Hosting (On dedicated & secured server)

4. Backup & Disaster Policy

5. Training

6. Training Certificates

7. Support (24X7) & maintenance via email, telephonically, remotely or personally

5. SUBMISSION OF THE EOI

It may be noted that this invitation should not be construed as a Tender/ Request for Proposal

(RFP) in any form and would not be binding on the institute in any manner whatsoever.

1. The expression of interest will be carried out through submission of online mode only. No

offer in physical form will be accepted and any such offer if received by CDSA will be out

rightly rejected. EoI documents can be downloaded from website of CPPP

www.eprocure.gov.in and Expression of interest is to be uploaded on same website i.e

www.eprocure.gov.in . The bidders should have a valid digital signature certificate

(Class'II or Class'III) issued by any of the valid Certifying Authorities to participate in the

online tender. The bids shall be uploaded in electronic form only on www.eprocure.gov.in

website. Before submission of bids, the bidders are requested to kindly read the

“INSTRUCTIONS FOR ONLINE EOI SUBMISSION” available at the end of this EoI document

2. The EoI Fee in the form of Demand Draft/Pay order drawn in favour of “Clinical

Development Services Agency” and payable at Gurgaon, Haryana towards cost of bid

documents shall be submitted to Admin and Finance Manager, CDSA, Faridabad by hand

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delivery/courier on or before the end date for submission of EoI failing which the EoI will

be rejected. The reference no. of the EOI and super scribing the word “EoI Fee” should be

specifically mentioned on the top of the envelope. The EoI fee envelope should be

submitted to the Program Director, CDSA, THSTI, NCR Biotech Science Cluster, 3rd

Milestone, Faridabad-Gurgaon Expressway, Faridabad by 08/05/2019 latest by 2:00 PM.

3. The EOI should be valid for 180 days from the date of opening. The organization / agency

who is submitting the offer is required to do so after visiting the institute and examining

the whole system.

4. All the pages of document being submitted must be signed and sequentially scanned by

the firm irrespective of nature or context of document before uploading

5. The application should be accompanied with the following information: -

A. A capability statement (Not more than two pages).

B. A write up on the understanding of the assignment with respect to the

aforementioned brief scope of work.

C. Company/ Organization profile giving details of current activities and

management structure.

D. Evidence of incorporation.

E. Annual report including balance sheet and profit and loss account statement for

the past three years.

6. Expectations from the professional organization/ agency: -

Apart from the scope of work described in earlier section, the agency is expected to

understand the specific needs of CDSA in this endeavour and come up with a complete plan.

The representatives from the organization / agency should interact with the concerned

officials/Investigators from CDSA during the pre EOI meeting to understand the requirement.

6. ELIGIBILITY CRITERIA

The agency / organization submitting the offer will be shortlisted, who are capable of

rendering high degree of professional services in the field. These short listed agencies may

be invited later to submit their proposals. Additionally, the agencies/organizations must fulfil

the following criteria:-

A. Should be a reputed and established company/ organization.

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B. Minimum experience of serving at least 2 similar clients and should have at least 3

years of providing CDMS for the development and designing of the study specific

Electronic Data Capture Platform as on 31 March 2019 .

C. The average annual financial turnover of the bidder during the last three years, ending

on 31 March 2018, should be at Rs. 12 Lakhs or more (or equivalent in foreign currency

at exchange rate prevalent on 31 March 2018) as per the annual report (audited

balance sheet and profit & loss account) of the relevant period, duly authenticated by

a Chartered Accountant/Cost Accountant in India or equivalent in relevant countries.

D. Bidder Firm (manufacturer or principal of authorised representative) should not have

suffered any financial loss for more than one year during the last three years, ending

on 31 March 2018

E. Should demonstrate the CDMS platform either through Skype or in person prior to

their proposal.

F. The organization should have capacity to deliver within 3 months from the allotment

of work order & should be able to support the platform (for runtime errors, server

downlink errors and any other system errors) for 3 years from the date of delivery.

G. Undertaking for never been black listed by Centre/State Government/any PSU/private

sector.

H. Registration with Income Tax and Service Tax authorities

I. Preference will be given to the agencies/consultants who are currently executing

similar type of work.

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7. EVALUATION METHODOLOGY

The methodology for finalization of work proposal will be in two stages, comprising the offer

for the said proposal in the first stage, and inviting the techno-commercial offer from the

qualified agency / organization in the second stage. The evaluation procedure for the

finalization of proposal would follow on the quality- cum cost-based system. The scoring

would be done on the basis of below parameters:

1. Professional competence of the bidder

2. CDMS features

3. Presentation and live demo

4. Experience of performing same set of work

A. Evaluation Criteria

1. Weightage allocation to Evaluation criteria

S. No. Criteria Weightage Breakup of

weightage

1 Previous experience of the firm with similar

requirement

10

A. 3 years and more with two similar clients 10

B. 1-3 years with two similar clients 5

C. Less than 1 years 0

2 Financial turnover 5

A Financial turnover of Rs 12 Lakhs and more 5

B Financial turnover of Rs 8- 12 Lakhs 3

C Financial turnover of less than Rs 8 Lakhs 0

3 Technical Capacity Criteria

1) Professional Competence of the

organization

A Capability statement (Not more than two

pages) and a write up on the understanding

of the assignment with respect to the

aforementioned brief scope of work.

2) Validated CDMS/ EDC Tool (21 CFR Part11

complaint) with mentioned features –

65

5

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S. No. Criteria Weightage Breakup of

weightage

A Total number of studies can be setup

B Total number of users can be created

C Provision of creation of Edit checks, range

checks, logic checks etc. within the system

D Discrepancy management (manual &

system generated queries) including

report generation

E External data load

F Job scheduler (Automated

alerts/notifications)

G Reports (standard and customized) at

management, study, site and patient level

for various users and levels in

excel/csv/SAS/pdf/word format

H Dashboard for management, study and site

level

I Integration with other tools such as IVRS

(Interactive Voice Response System), IWRS

(Interactive Web Response System), Lab

normalization, Imaging, Biorepository,

Barcode scanner, CTMS (Clinical Trial

Management System) etc.

J Audit trail

K Data Synchronization:

- Real Time

- Offline mode (automatic synchronization

in the range of internet)

L Hosting charges (Study based/ flat charges)

5

5

5

5

5

5

5

5

5

5

5

5

3 Quality accreditations and licensing

requirement

10

4 Presentation and live demo 10

This evaluation sheet will be filled in by the interested bidder and uploaded in .xls ( Microsoft excel) format in the evaluation folder

B. Evaluation Criteria of Technical Bid

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The Technical Bids shall be evaluated and the scores will be given as per the above

criteria. High scoring Bids (70 marks out of 90) based on the financial and technical

capacity criteria shall be shortlisted and invited for presentation.

The shortlisted bidders will be called for a brief interaction cum presentation before a

committee. Each of such session will be of 30 minutes duration. During interaction/

presentation, the shortlisted bidders will be rated on the following parameters:

Ability to communicate the organizational expertise

Understanding of scope of work

Ability to communicate the tentative plan for execution of the scope of work

All bidders getting total score of 75 and more will be shortlisted for the submission of the

RFP involving submission of the techno commercial bids.

The cost associated with the preparation and submission of the proposal shall be borne by the

bidder.

8. TERMS OF REFERENCE

Terms of reference for the proposal outlining the techno-commercial offer are as

follows:-

A. Only shortlisted Organizations will be issued techno-commercial documents,

wherein technical and financial offers are to be submitted separately.

B. Program Director, CDSA reserves the right to cancel/withdraw the process if

necessity so arises, or to seek further information/details.

C. Organization / Agency found to have indulged in any corrupt or fraudulent

practices will be out rightly rejected.

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9. APPLICATION FORM

For

Procurement of Clinical Data Management System (CDMS)/ EDC (Electronic Data

Capture) tool at Clinical Development Services Agency (CDSA), THSTI, NCR

Biotech Science Cluster, Faridabad

To,

Program Director, Clinical Development Services Agency 3rd Floor, Translational Health Science and Technology Institute building Third milestone, Gurugram - Faridabad Expressway, Faridabad, Haryana Madam, Having examined the EoI document the receipt of which is hereby duly acknowledged, we the undersigned offer to supply and deliver ___________________________(Description of Goods) in conformity with the EOI document. We agree to abide by this EoI for requisite period as fixed in the bid document and as per the instructions to the bidders. Further it shall remain binding upon us and accepted at any time before the expiry of that period. The details of our firm are as follows:

1. Name:

2. Mailing Address:

3. Telephone & Fax number:

4. E-mail Address:

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5. Name and Designation of the person

CDSA, FARIDABAD.

6. Year of establishment and

constitution of the organization:

7. Establishment registration details

with PAN and GST

8. Details of Management:

9. Whether the firm/ organization has any widely accepted certifications. If yes, furnish certified copies:

10. Turnover for the last three years:

11. List of projects in the last three years in which firm/ organization/consultant has

delivered services similar to that in proposed advertisement:

Name of the Project

Year Country Value Recipient’s Name

Short description of the Project

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12. Whether the following documents have been enclosed with the application:-

(This checklist to be uploaded in excel format also

1 A capability statement Yes/ No

2 A write up on the understanding of the assignment

after site inspection.

Yes/ No

3 Company/ Organization profile giving details of

current activities and management structure

Yes/ No

4 Evidence of incorporation Yes/ No

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5 Annual report including balance sheet and profit

and loss account statement for the past three

Years /Income tax related documents.

Yes/ No

6 Evaluation sheet in the Evaluation folder Yes/No

(Signature of the Bidder)

Name:

Place:

Date:

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10. INSTRUCTIONS FOR ONLINE SUBMISSION

(Department User may attach this Document as an Annexure in their Tender Document which

provides complete Instructions for on line Bid submission for Bidders)

The bidders are required to submit soft copies of their bids electronically on the CPP Portal,

using valid Digital Signature Certificates. The instructions given below are meant to assist the

bidders in registering on the CPP Portal, prepare their bids in accordance with the requirements

and submitting their bids online on the CPP Portal.

More information useful for submitting online bids on the CPP Portal may be obtained at:

https://eprocure.gov.in/eprocure/app.

REGISTRATION

1) Bidders are required to enroll on the e-Procurement module of the Central Public

Procurement Portal (URL: https://eprocure.gov.in/eprocure/app) by clicking on the link

“Online bidder Enrollment” on the CPP Portal which is free of charge.

2) As part of the enrolment process, the bidders will be required to choose a unique

username and assign a password for their accounts.

3) Bidders are advised to register their valid email address and mobile numbers as part of

the registration process. These would be used for any communication from the CPP

Portal.

4) Upon enrolment, the bidders will be required to register their valid Digital Signature

Certificate (Class III Certificates with signing key usage) issued by any Certifying

Authority recognized by CCA India (e.g. Sify / nCode / eMudhra etc.), with their profile.

5) Only one valid DSC should be registered by a bidder. Please note that the bidders

are responsible to ensure that they do not lend their DSC’s to others which may lead to misuse.

6) Bidder then logs in to the site through the secured log-in by entering their user ID

/ password and the password of the DSC / e-Token.

SEARCHING FOR TENDER DOCUMENTS

1) There are various search options built in the CPP Portal, to facilitate bidders to

search active tenders by several parameters. These parameters could include Tender

ID, Organization Name, Location, Date, Value, etc. There is also an option of advanced

search for tenders, wherein the bidders may combine a number of search parameters

such as Organization Name, Form of Contract, Location, Date, Other keywords etc. to

search for a tender published on the CPP Portal.

2) Once the bidders have selected the tenders they are interested in, they may download

the required documents / tender schedules. These tenders can be moved to the respective ‘My

https://eprocure.gov.in/eprocure/app

https://eprocure.gov.in/eprocure/app

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Tenders’ folder. This would enable the CPP Portal to intimate the bidders through SMS / e-

mail in case there is any corrigendum issued to the tender document.

3) The bidder should make a note of the unique Tender ID assigned to each tender, in

case they want to obtain any clarification / help from the Helpdesk.

PREPARATION OF BIDS

1) Bidder should take into account any corrigendum published on the tender document

before submitting their bids.

2) Please go through the tender advertisement and the tender document carefully to

understand the documents required to be submitted as part of the bid. Please note

the number of covers in which the bid documents have to be submitted, the number of

documents - including the names and content of each of the document that need to

be submitted. Any deviations from these may lead to rejection of the bid.

3) Bidder, in advance, should get ready the bid documents to be submitted as indicated in

the tender document / schedule and generally, they can be in PDF / XLS / RAR /

DWF/JPG formats. Bid documents may be scanned with 100 dpi with black and white

option which helps in reducing size of the scanned document.

4) To avoid the time and effort required in uploading the same set of standard

documents which are required to be submitted as a part of every bid, a provision of

uploading such standard documents (e.g. PAN card copy, annual reports, auditor

certificates etc.) has been provided to the bidders. Bidders can use “My Space” or ‘’Other

Important Documents’’ area available to them to upload such documents. These

documents may be directly submitted from the “My Space” area while submitting a bid,

and need not be uploaded again and again. This will lead to a reduction in the time

required for bid submission process.

Note: My Documents space is only a repository given to the Bidders to ease the uploading process. If

Bidder has uploaded his Documents in My Documents space, this does not automatically ensure

these Documents being part of Technical Bid.

SUBMISSION OF BIDS

1) Bidder should log into the site well in advance for bid submission so that they can

upload the bid in time i.e. on or before the bid submission time. Bidder will be

responsible for any delay due to other issues.

2) The bidder has to digitally sign and upload the required bid documents one by one

as indicated in the tender document.

3) Bidder has to select the payment option as “offline” to pay the tender fee / EMD as

applicable and enter details of the instrument.

4) Bidder should prepare the EMD as per the instructions specified in the tender

document. The original should be posted/couriered/given in person to the concerned

official, latest by the last date of bid submission or as specified in the tender documents.

The details of the DD/any other accepted instrument, physically sent, should tally with

the details available in the scanned copy and the data entered during bid submission

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time. Otherwise the uploaded bid will be rejected.

5) Bidders are requested to note that they should necessarily submit their financial bids in

the format provided and no other format is acceptable. If the price bid has been

given as a standard BoQ format with the tender document, then the same is to be

downloaded and to be filled by all the bidders. Bidders are required to download the

BoQ file, open it and complete the white coloured (unprotected) cells with their

respective financial quotes and other details (such as name of the bidder). No other

cells should be changed. Once the details have been completed, the bidder should

save it and submit it online, without changing the filename. If the BoQ file is found to

be modified by the bidder, the bid will be rejected.

6) The server time (which is displayed on the bidders’ dashboard) will be considered as the

standard time for referencing the deadlines for submission of the bids by the

bidders, opening of bids etc. The bidders should follow this time during bid submission.

7) All the documents being submitted by the bidders would be encrypted using PKI encryption techniques to ensure the secrecy of the data. The data entered cannot be viewed by unauthorized persons until the time of bid opening. The confidentiality of the bids is maintained using the secured Socket Layer 128 bit encryption technology. Data storage encryption of sensitive fields is done. Any bid document that is uploaded to the server is subjected to symmetric encryption using a system generated symmetric key. Further this key is subjected to asymmetric encryption using buyers/bid opener’s public keys. Overall, the uploaded tender documents become

readable only after the tender opening by the authorized bid openers.

7) The uploaded tender documents become readable only after the tender opening by

the authorized bid openers.

8) Upon the successful and timely submission of bids (i.e. after Clicking “Freeze Bid

Submission” in the portal), the portal will give a successful bid submission message & a

bid summary will be displayed with the bid no. and the date & time of submission of

the bid with all other relevant details.

9) The bid summary has to be printed and kept as an acknowledgement of the submission

of the bid. This acknowledgement may be used as an entry pass for any bid opening

meetings.

ASSISTANCE TO BIDDERS

1) Any queries relating to the tender document and the terms and conditions contained

therein should be addressed to the Tender Inviting Authority for a tender or the

relevant contact person indicated in the tender.

2) Any queries relating to the process of online bid submission or queries relating to

CPP Portal in general may be directed to the 24x7 CPP Portal Helpdesk.

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