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    Central Laboratory Services for Clinical Trial

    BiconY Therapeutics GmbH

    Central Laboratory Services for Clinical Trial

    1. Competition notice published

      Oct 3, 3:59 PMOctober 3, 2026 3:59 PM

    2. Questions deadline

      Oct 26, 10:59 PMOctober 26, 2026 10:59 PM

    3. Tender submission deadline

      Nov 4, 10:00 AMNovember 4, 2026 10:00 AM

    4. Opening date

      Nov 4, 10:01 AMNovember 4, 2026 10:01 AM

    5. Tender validity period

      Dec 30, 10:00 AMDecember 30, 2026 10:00 AM

    Brief

    Germany: Tenders/BiconY Therapeutics GmbH/Central Laboratory Services for Clinical Trial
    Brief

    Helse- og sosial tjenesteyting

    BiconY Therapeutics GmbH needs central laboratory services for two phase I/IIa clinical trials over 18 months. The services include collection logistics, processing, analysis, management, distribution, and long-term storage of biological specimens, specifically cytokine analysis in serum and isolation of peripheral blood mononuclear cells (PBMC). The central laboratory must be accredited according to ISO 15189 (or equivalent, e.g., CAP/CLIA) and operate in compliance with GCP/GCLP. Suppliers must provide at least five references as a central laboratory in clinical studies with cytokine multiplex analysis and/or specimen management since October 1, 2022, and submit a self-declaration on compliance with Good Clinical Practice (ICH E6) and GDPR.

    About the bid

      The Federal Agency for Disruptive Innovation - SPRIND GmbH ("SPRIND") - aims to create new disruptive innovations from Germany. That means products, services and systems that make all our lives noticeably and sustainably better. To achieve this, SPRIND brings together new thinkers from science and business, people with outstanding ideas, special expertise, and passion. Hence, SPRIND provides an entrepreneurial environment that turns ideas into reality. The objective of BiconY Therapeutics GmbH, a SPRIND subsidiary, is the development of a bispecific antibody combination for the treatment of solid tumours. The combination consists of proprietary, bispecific CD3 anti-bodies (bsAbCD3) and bispecific CD28 co-stimulators (BiCos), which, when used together, significantly improve the specificity, sustainability, and efficiency of a T cell recruitment and thus the immune response against tumour cells. The aim of the research and development activities is to provide proof of concept for the effect of bispecific antibody therapy in the form of two phase I/IIa clinical trials. For the conduct of the planned phase I/IIa clinical trials, comprehensive central laboratory services are required for the collection logistics, processing, analysis, management, distribution and long-term storage of the biological specimens obtained from the trial participants. This includes in particular the analysis of cytokines in serum and the isolation of peripheral blood mononuclear cells (PBMC). Therefore, BiconY is looking for a service provider to act as central laboratory for these clinical trials. Please refer to the tender documents for further details.Main features of the procedureThis is an e open procedure. No negoatiations will take place.

      Contact phone
      +49 69 7191890-12
      Contact email
      bicony.tenderprocedure@fgvw.de
      Address
      Lagerhofstraße 4, 04103 Leipzig

    Custom Assessment Criteria

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    Award Criteria

      Found no award criteria in the contract notice.

    Qualification requirements

    • Description

      Leverandøren skal fremlegge minst fem referanser som sentralt laboratorium i kliniske studier med cytokin-multiplexanalyse og/eller prøvehåndtering siden 1. oktober 2022. Hver referanse må enten være fullført eller pågående. Ved pågående referanser må spesifikasjoner av planlagt/kontraktuell prosjektvarighet og informasjon om gjeldende status inkluderes. Det er irrelevant om referanseleverandøren er et offentlig eller privat selskap. BiconY forbeholder seg retten til å verifisere de oppførte studiene med sponsorene. Minimumskrav for hver av de fem referansene: 1. Siden 1. oktober 2022. 2. Fullført og pågående referanse; hvis pågående, må spesifikasjoner av planlagt/kontraktuell prosjektvarighet og informasjon om gjeldende status for referanseprosjektet inkluderes. 3. Den respektive referansen må være som sentralt laboratorium i kliniske studier med cytokin-multiplexanalyse og/eller prøvehåndtering.

      Documentation Requirement

      Bruk skjemaet "03_Egenerklæring for tilbudsgiveres egnethet" for å oppgi referansene.

    • Description

      Det sentrale laboratoriet skal være akkreditert i henhold til ISO 15189 (eller tilsvarende, f.eks. CAP/CLIA) og operere i samsvar med GCP/GCLP (Good Clinical Laboratory Practice). Hvis mer enn ett anlegg er involvert, må en separat akkreditering/sertifikat være tilgjengelig for hvert anlegg.

      Documentation Requirement

      En kopi av det relevante sertifikatet må vedlegges tilbudet.

    • Description

      Egenerklæring om overholdelse av Good Clinical Practice (ICH E6) og gjeldende databeskyttelseskrav (GDPR / Forordning (EU) 2016/679) for håndtering av humane biologiske prøver og tilhørende data, sammen med relevant implementert nasjonal lovgivning (eller sammenlignbare regler der en bestemmelse ikke gjelder for tilbyderen/tilbyderkonsortiet).

      Documentation Requirement

      Egenerklæring skal leveres.

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    See the full notice

    Contracting authority
    BiconY Therapeutics GmbH
    Title
    Central Laboratory Services for Clinical Trial
    Type
    CompetitionPrequalification
    Main code
    85100000Health services
    Supplemental codes

    No supplemental codes from buyer…

    Duration
    18 months

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