Preclinical & Clinical Operations

SOLUTION 3

From preclinical evidence to clinical proof-of-concept

Integrated Solutions for Early-Stage Assets

subrosa designs, coordinates and delivers services across the critical stages from early scientific development to clinical-trial execution — shortening timelines and translating data into robust, compliant and investable development programs that de-risk assets at the critical transition into human studies.

We provide a capital-efficient globalization platform for early-stage and rare-disease assets, making them investable (preclinical), approvable and competitive (clinical), used and reimbursed (medical).

Preclinical & Clinical

Preclinical Solutions

We support you to transform local preclinical programs into globally investable assets.

Preclinical services encompass the scientific, regulatory and strategic activities required to prepare a drug candidate for first-in-human testing. This phase bridges early discovery and clinical development by generating the safety, pharmacology and feasibility data needed to support regulatory engagements.

subrosa combines the knowledge, experience and insights of our clinical, medical, regulatory, market-access, commercial and capital units to help early biotechs and university spin-offs in the preclinical stage develop a global asset & regulatory strategy and the TPP design — to de-risk and prepare for global entry. Board- and investor-ready.

Our Global Networks across KOLs, C-suite leaders, capital sources and top talent give us direct access to potential co-development partners, grants, funding sources, executives and scientific & preclinical development management.

Our Integrated Engagements in the Preclinical Phase

01Global Asset Strategy & Positioning
02Target Product Profile (TPP) Design
03Regulatory Pathway Strategy (FDA / EMA / PMDA / NMPA-SFDA)
04Early-Stage External KOL Input
05BD Readiness for Investor
06Co-Development Partnering
07Fund & Grants Raising
08Executive Search & Recruitment
09Special: University Spin-Offs
10CFO-Services
Prof. Arndt Rolfs
Your contact for Preclinical Prof. Arndt Rolfs Chief Medical Officer · CEO subrosa OmicsAI
Michael Kring
Your contact for Preclinical Michael Kring Expert Early Biotechs · Funds & M&A
Preclinical & Clinical

Clinical Operations

“We help to ensure your clinical program answers the questions regulators, payers and physicians actually care about.”

Many trials from startup and orphan-drug developers are optimized for regulatory approval, yet fall short of meeting reimbursement or physician expectations. The root causes often include a limited variety of inclusion criteria, endpoints that lack real-world relevance, and insufficient alignment with KOLs and payers.

subrosa Clinical Operations Services combine the knowledge, experience and insights of our clinical, medical, regulatory, market-access, commercial and capital units to bring medical-affairs and investor thinking early into clinical design.

Our integrated services support the originator’s clinical strategy, study design and study-site selection. Our rare-disease early patient genome database normally reveals additional symptoms (inclusion criteria) of young patients that have not been published so far. On that basis we recruit patients for trials through clinical programs in every market globally with a reliable outcome — patients in a development phase, years earlier than today’s standards. Where it makes sense, we develop biomarkers successfully (multiple proven) and deploy Sponsor Trial Liaison (STL) or Clinical Trial Medical Liaison (CTML) field teams, helping sponsors accelerate delivery while improving trial quality and readiness for later commercialization.

Our Global Networks across KOLs, C-suite leaders, capital sources and top talent give us direct access to medical, development and clinical-operations executives and management, as well as to potential co-development partners and funds.

Our Integrated Solutions for Clinical Operations

01Clinical Strategy & Study Design
02Investigator / KOL Network Activation
03Study-Site Selection Support
04Clinical Early Patient Recruitment Programs
05Patient Registration
06Biomarker Development
07Deployed Field Teams (STL, CTML, VTL) 08Executive Search & Recruitment
09Co-Development Partnering
10Fund Raising
Yasmin Walker
Your contact for Clinical Operations Yasmin Walker Head of Operations · subrosa Health & Capital
Preclinical & Clinical

Clinical Field Teams

Sponsor-deployed liaison teams to accelerate delivery and improve trial quality.

Sponsor Trial Liaison
STL

  • Represent the sponsor
  • Monitor the CRO / CRAs
  • Main contact for investigators
  • Conduct Site Initiation Visits (SIVs)
  • Support patient enrollment
  • Optimize study-time management

Clinical Trial Medical Liaison
CTML

  • Explain the mechanism of action
  • Build relationships with HCPs, KOLs & investigators
  • Conduct Site Initiation Visits (SIVs)
  • Support patient enrollment
  • Optimize study-time management

Virtual Trial Liaison
VTL

  • Represent the sponsor
  • Support patient enrollment
  • Fast investigator and study support
  • Link between CRO / sponsor in-house & field teams
  • Logistics support for study material
  • Optimize study-time management
Preclinical & Clinical

STL vs MSL

Two distinct field roles — complementary, with different mandates and timings.

Sponsor Trial Liaison
STL

  • Explains compound & clinical trial / endpoints to reach / patient benefit
  • Builds relationships with study sites and investigators, top KOLs
  • Supports patient enrollment / bridge from clinical to medical (3–5 years prior to product launch)
  • Represents the sponsor — link between CRO – sponsor – investigator

Medical Science Liaison
MSL

  • Explains the mechanism of action, development in the therapeutic area, patient benefit
  • Builds relationships with HCPs, KOLs and main organizations, raises disease awareness
  • Supports IITs, Early Access, Ad Boards (1–2 years prior to launch — launch — on market)

Trusted by leading life-science companies worldwide.

AbbottAbbVieAbdiAbnobaAccordActelionActoBioAdvanzAdverum BioAegleaAgendiaAgiosAidianAimmuneAkceaAlbireoAlexionAlimeraAllerganAlmirallAlnylamAmarinAmgenAmicusAmrytAmylyxAngeliniAntaresApellisApontisArenaArgenxArmoArvelleAscendisAspenAstellasAstraZenecaAutolusAuxiliumAviaAvidityAzur PharmaB.BraunBasileaBausch & LombBavarian NordicBaxaltaBaxterBayerBeamBeiersdorfBeiGeneBeOneBesinsBIALBioCrystBiogenBiomarinBiometBioNTechBioprojetBiovailBluebird bioBlueprintBMSBoehringer IngelheimBoironBoston ScientificCamarusCarl ZeissCephalonChiesiChugaiClovisColgateCrineticsCSLcurrentzzCytokineticsDaiichi-SankyoDanoneDecipheraDenaliDiurnalDompeDr. FalkEisaiEsteveEUSAExact SciencesFerrerFerringFreseniusFujisawaGalapagosGaldermaGE HealthcareGedeon RichterGentiliGileadGrifolsGrünenthalGSKGTx Inc.Guardant HealthGW pharmaceuticalsHAL AllergieHaleonHalozymeHexalHorizonIdorsiaIncyteInterceptIntrexonIpsenItalfarmacoITF PharmaITMJ&JKaro PharmaKiadisKiteKlingeKyowa KirinLeo PharmaLigandLillyLindeLohmann & RauscherLundbeckLupinLyrixLyvyenLórealMadrigalMallinckrodtMead JohnsonMedacMediceMedImmuneMedtronicMenariniMerck SeronoMereoMerzMetrioPharmMiratiMirumMithraMSDMundipharmaMylanMyriadMölnlyckeNeopharmedNestléNikonNiproNordic PharmaNorgineNovartisNovavaxNovo NordiskNovocureOlympusOncoBetaOncopeptidesOnoOrionOrphalanOtsukaOvivaP&GPaul HartmannPfizerPharma&PharmacosmosPhytogenPierre FabrePiramalPortolaPrecigenProthenaQLTReckittRecodartiRegeneronResMedRevolution MedicinesRhythmRocheSageSalixSandozSanofiSantenSareptaScholar RockSeagenSenturiSeqirusServierShireSiemens HealthineersSmith & NephewSOBISpringsworksStebaStemlineStragenStridesStrykerSunovionTakedaTDSTenxTesaroTetrisTevaTherabelThermo FisherThromboGenicsTiberTorrentUS SurgicalUCBUnileverUriachValeantValnevaVernalisVertexViatrisVicuronViforViiVVygonYamanouchiZambonZogenixAbbottAbbVieAbdiAbnobaAccordActelionActoBioAdvanzAdverum BioAegleaAgendiaAgiosAidianAimmuneAkceaAlbireoAlexionAlimeraAllerganAlmirallAlnylamAmarinAmgenAmicusAmrytAmylyxAngeliniAntaresApellisApontisArenaArgenxArmoArvelleAscendisAspenAstellasAstraZenecaAutolusAuxiliumAviaAvidityAzur PharmaB.BraunBasileaBausch & LombBavarian NordicBaxaltaBaxterBayerBeamBeiersdorfBeiGeneBeOneBesinsBIALBioCrystBiogenBiomarinBiometBioNTechBioprojetBiovailBluebird bioBlueprintBMSBoehringer IngelheimBoironBoston ScientificCamarusCarl ZeissCephalonChiesiChugaiClovisColgateCrineticsCSLcurrentzzCytokineticsDaiichi-SankyoDanoneDecipheraDenaliDiurnalDompeDr. FalkEisaiEsteveEUSAExact SciencesFerrerFerringFreseniusFujisawaGalapagosGaldermaGE HealthcareGedeon RichterGentiliGileadGrifolsGrünenthalGSKGTx Inc.Guardant HealthGW pharmaceuticalsHAL AllergieHaleonHalozymeHexalHorizonIdorsiaIncyteInterceptIntrexonIpsenItalfarmacoITF PharmaITMJ&JKaro PharmaKiadisKiteKlingeKyowa KirinLeo PharmaLigandLillyLindeLohmann & RauscherLundbeckLupinLyrixLyvyenLórealMadrigalMallinckrodtMead JohnsonMedacMediceMedImmuneMedtronicMenariniMerck SeronoMereoMerzMetrioPharmMiratiMirumMithraMSDMundipharmaMylanMyriadMölnlyckeNeopharmedNestléNikonNiproNordic PharmaNorgineNovartisNovavaxNovo NordiskNovocureOlympusOncoBetaOncopeptidesOnoOrionOrphalanOtsukaOvivaP&GPaul HartmannPfizerPharma&PharmacosmosPhytogenPierre FabrePiramalPortolaPrecigenProthenaQLTReckittRecodartiRegeneronResMedRevolution MedicinesRhythmRocheSageSalixSandozSanofiSantenSareptaScholar RockSeagenSenturiSeqirusServierShireSiemens HealthineersSmith & NephewSOBISpringsworksStebaStemlineStragenStridesStrykerSunovionTakedaTDSTenxTesaroTetrisTevaTherabelThermo FisherThromboGenicsTiberTorrentUS SurgicalUCBUnileverUriachValeantValnevaVernalisVertexViatrisVicuronViforViiVVygonYamanouchiZambonZogenix

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