Public Bidding Notice for Commissioned Technical Services: Phase I Trial of Recombinant Human Serum Albumin, Shenzhen Proji Pharmaceutical Technology Co., Ltd.

Published Time:

2018-09-10 12:04


  1. Bidding Conditions

   This bidding project is for the entrustment of technical services for Phase I trials of recombinant human serum albumin by Shenzhen Progige Pharmaceutical Technology Co., Ltd. The project R&D funds are self-raised by the company, and the bidder is Shenzhen Progige Pharmaceutical Technology Co., Ltd. The project has met the bidding conditions, and now the project is publicly tendered.

2. Project Overview and Bidding Scope

2.1 Project Overview

  Entrustment of technical services for Phase I trials of recombinant human serum albumin.

2.2 Bidding Content

   Entrustment of technical services for Phase I trials of recombinant human serum albumin (including ethical approval, filing with the Ministry of Science and Technology's Genetic Office, preparation of trial materials, trial initiation, central review, central management, central closure, pharmacovigilance, data management report review, statistical analysis report review, project management, quality assurance, self-inspection and verification, summary report review, etc.).

2.3 Cooperation Location

   Shenzhen Progige Pharmaceutical Technology Co., Ltd., Contract Research Organization (CRO), Clinical Trial Center.

2.4 Quality Requirements

   Including but not limited to "Good Clinical Practice for Drug Clinical Trials", "Good Quality Control for Drug Non-clinical Studies", "Guiding Principles for Phase I Clinical Trials (Trial) (2011 Year)", "2015 Edition of the Chinese Pharmacopoeia 9011 Guiding Principles for Human Bioavailability and Bioequivalence Trials of Drug Preparations", and "Technical Guiding Principles for Clinical Trials of Antitumor Drugs" (No. 122, 2012).

3. Bidder Qualification Requirements

3.1 Qualification Requirements: Bidders must have independent legal person status and clinical trial technical service qualifications, and have corresponding clinical trial project management and quality assurance capabilities.

3.2 Joint bids are not accepted for this tender.

3.3 Each bidder prepares a bid document for the above-mentioned project.

4. Obtaining Bidding Documents

4.1 Bidder Qualification Review: Those who intend to participate in the bidding should submit a copy of the bidding announcement screenshot, business license, tax registration certificate, organization code certificate, relevant qualification certificates, a list of Phase I projects undertaken in the past 3 years and review situation, and contact information of the bidder, etc., with the company seal, and send the scanned copy to the bidder (chenyang@protgen.com) via e-mail before September 28, 2018. Then submit the original document to the bidder, and the bidder conducts a qualification review of the bidder, selects the shortlisted enterprises, and will feedback the review results to the bidder within 1-2 working days after submitting the documents. 4.2 Within one workday of determining the shortlisted enterprises, the bidder will contact the shortlisted enterprises and send the bidding documents.

5. Submission of Bidding Documents

5.1 Deadline for submission of bidding documents: 17:00, October 15, 2018. Address: Room 310, Life Sciences Building, Tsinghua University, Haidian District, Beijing. Contact person: An Yajun, Contact number: 13699223097.

5.2 Bidding documents that arrive late or are not delivered to the designated location will not be accepted by the bidder. 6. Media for Publishing the Announcement

This bidding announcement is published on the Progige company website, URL: http://www.protgen.com/.

7. Special Notes

This bidding project does not accept bids from bidders who have not obtained the bidding documents. Alternative bidding schemes are not accepted for this bidding project.

8. Contact Information

   Bidder: Shenzhen Progige Pharmaceutical Technology Co., Ltd.

Office Address: 11th Floor, Building B,福田国际创新中心, No. 1006 Shennan Avenue, Shatou Street, Futian District, Shenzhen.

   Contact Person: Chen Yang

   Telephone: 13826503743 Email: chenyang@protgen.com

   联系人:陈洋

电话:13826503743

电子邮箱:chenyang@protgen.com

  

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