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PROCESSING TOR-301Reading protocol synopsis12 questionsExtracting study parameters185 data pointsSearching answer library196 answersMatching prior bids140 defendedChecking site network2,314 sitesDrafting responses12 of 12FIELDS ANSWERED1558104149185
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XTOR-301_RFI_answers.xlsxQUESTIONANSWER1Therapeutic experience0100101101001011010study count Crohn's studies delivered2Prior Phase II delivery0100101101001011010phase II studies studies, patients screened pts3Median start-up0100101101001011010start-up days to first activation4Country footprint0100101101001011010countries countries, site count sites5Monitoring model0100101101001011010Risk-based, CMP version6Screen failure rate0100101101001011010screen failure across recent studies7Named investigators0100101101001011010investigator count named, PI contacts reachable
Torsana_TOR-301_RFI_Response
Torsana Therapeutics · Crohn's disease · Phase II · due in 21 days
QuestionsSourcesReview
12 questions4 drafted12 drafted5 have gaps0 gaps3 need you
Company viability, ownership and headcountCorporate & CommercialSourcedSite monitoring approach and visit cadenceClinical OperationsSourcedPhase II gastroenterology studies deliveredClinical OperationsHas gapsSourcedMedian time from selection to first activationClinical OperationsHas gapsSourcedScreen failure rates in recent Crohn's studiesData SciencesHas gapsSourcedNamed Phase II GI investigators you have usedFeasibilityNeeds youCountry footprint and regulatory coverageRegulatory AffairsSourcedData management and EDC configurationBiometricsHas gapsSourcedPharmacovigilance and safety reportingMedical & SafetySourcedQuality system, audits and inspection historyQuality AssuranceSourcedLocal vendor list for Poland and NetherlandsRegulatory AffairsNeeds youRisk-based monitoring plan and CTQ factorsClinical OperationsNeeds you
ANSWERED12 of 129 drawn from memory 3 with a named owner
ASKING YOUR EXPERTS
TWELVE OF TWELVE ANSWERED
SPONSOR REPLIED
XTOR-301_RFI_answers.xlsxQUESTIONANSWER1Therapeutic experiencestudy count Crohn's studies delivered2Prior Phase II deliveryphase II studies studies, patients screened pts3Median start-upstart-up days to first activation4Country footprintcountries countries, site count sites5Monitoring modelRisk-based, CMP version6Screen failure ratescreen failure across recent studies7Named investigatorsinvestigator count named, PI contacts reachable8Local vendor list, PL and NLSME input pendingBoth countries covered, list attachedM. Lindqvist9Named Phase II GI investigatorsSME input pendingSix PIs from MOP-GI-0004, all reachableJ. Feldt10Risk-based monitoring and CTQSME input pendingSeven CTQ factors agreed, CMP v6T. RiveraALL TWELVE ANSWEREDREADY TO SEND
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01101001011010010110100101
Microsoft TeamsMLMara LindqvistRegulatory AffairsChatYQ11 · Local vendor list, Poland and Netherlands?Mara Lindqvist is typingMLBoth countries covered. List attached.Microsoft TeamsJFJonas FeldtFeasibilityChatYQ6 · Named Phase II GI investigators you have used?Jonas Feldt is typingJFSix PIs from MOP-GI-0004, US and APAC, all reachable.Microsoft TeamsTRTomas RiveraClinical OperationsChatYQ12 · Risk-based monitoring plan and CTQ factors?Tomas Rivera is typingTRCTQ set agreed. Seven factors, CMP v6 applies.
Send to sponsorSent
OOutlook · procurement@torsana.comTorsana TherapeuticsRE: TOR-301, please proceed to full proposalnowTorsana TherapeuticsTOR-301 site list, follow up09:12Torsana TherapeuticsBid defence schedulingTueMeridian Oncology PartnersTOR-301 feasibility kick-offMon
Nine of the twelve answers come straight from studies Meridian has already
delivered, and each one carries the study ID it came from. You can check any of them.
The other three carry a name rather than a citation, because they should.
Happy to walk you through either.
WTorsana_TOR-301_RFI_Response.docx · 2.4 MBRFI response sent. Nothing left on your desk.
Sponsor requested a full proposal
WTorsana_TOR-301_RFP.docx
Request for proposal, full service delivery, 5 countries
PTOR-301_Protocol_Synopsis_v2.docx
Phase II, anti-TL1A antibody, moderate to severe Crohn's disease
2,314 organizations match · ranked on delivery, not on claim41 shortlisted9 under-delivered4 with no enrolment record
Research site
Connection
Promised · delivered
Record
Ashbourne Oncology, Houston
Strong (8)
28 / 26
Delivered
Silverdale Institute, Seville
Strong (7)
31 / 29
Delivered
Ravenscourt Gastro, Krakow
Good (5)
22 / 20
Delivered
Kitagawa Medical, Osaka
No communication (0)
30 / --
No enrolment record
Thornbury Comprehensive, Melbourne
Weak (4)
26 / 14
Under-delivered
Ironwood Regional, Chicago
Good (6)
24 / 23
Delivered
Everleigh Medical, Gdansk
Good (5)
19 / 18
Delivered
Marlowe Institute, Sydney
Weak (3)
21 / 11
Under-delivered
DELIVERY PLAN UNDER VALIDATIONCountryASSUMEDYOUR RECORDUnited States11 wks79dSpain13 wks93dPoland10 wks96dJapan11 wks79dAustralia11 wks77d
FEASIBILITY OUT · 41 SITESUnited States14Spain9Poland8Japan6Australia4
RESPONDED OF 41011233134
FLAGGED
Plan assumes 10 weeks to first activation in Poland.
Your last 73 Polish sites: 96 days median.
Re-sequenced. Slowest country starts first.
Feasibility report
TOR-301 · 41 sites contacted · 34 responded · median 6 days
Approve planApproved
DashboardResponsesEnrolment
TOTAL SUBMISSIONS34ACTIVE PATIENTS IN DATABASE413TOTAL PATIENT COMMITMENT420MEDIAN RESPONSE TIME6 days
Site
City
Capacity
Replied
Ashbourne Oncology & Hematology
Houston
18
4 days
Silverdale Cancer Institute
Seville
14
6 days
Ravenscourt Gastroenterology
Krakow
11
9 days
Kitagawa Medical Center
Osaka
0
no response
Thornbury Comprehensive
Melbourne
12
5 days
Ironwood Regional Cancer
Chicago
9
7 days
Everleigh Medical Center
Gdansk
8
11 days
CONFIRMED CAPACITY420 OF 420388 confirmed, 4 backup sites close the gap
Reported patient access by siteAshbourne150Silverdale100Thornbury58CRC workload and availabilityAshbourne25Silverdale20Thornbury12Priority assigned to this protocolTop 10 priority 40%Top 3 priority 40%Lower priority 20%Primary constraints to performancePI bandwidth2Patient access1Drug logistics1
Projected enrolment, week 21 to week 79
FEASIBILITY REPORT · APPROVED34 of 41responded420confirmedwk 21first patient inAshbourne150Silverdale100Thornbury58
COUNTRY AND SITE ALLOCATION · VALIDATED
0110100101101001
Budget
TOR-301 · 41 sites · 420 patients · 18 months
By functionPass-throughAssumptions
Professional fees
Share
Amount
Clinical
39.7%
EUR 3.29M
Project management
24.6%
EUR 2.04M
Regulatory and start-up
8.6%
EUR 0.71M
Medical
7.1%
EUR 0.59M
Biostatistics
4.1%
EUR 0.34M
Data management
3.9%
EUR 0.32M
Other functions
12.0%
EUR 0.99M
Pass-through and grants
Share
Amount
Investigator grants
17.0%
EUR 3.13M
Laboratory
11.0%
EUR 2.02M
Travel and site meetings
6.2%
EUR 1.14M
Central services and technology
5.8%
EUR 1.07M
TOTAL STUDY BUDGETEUR 18.4Mprofessional fees EUR 8.28MProfessional fees 45%Pass-through 24%Investigator grants 17%Laboratory 11%Inflation 3%
TOR-301 proposal
Torsana Therapeutics · due in 21 days
RFI response12 of 12 answeredCountry and site strategy5 countries, 41 sitesFeasibility report34 responded, 420 coveredBudgetEUR 18.4M on your own rates
Professional feesHOURSSHAREAMOUNTClinical21,90039.7%EUR 3.29MProject management13,60024.6%EUR 2.04MRegulatory and start-up4,7508.6%EUR 0.71MMedical3,9207.1%EUR 0.59MBiostatistics2,2604.1%EUR 0.34MData management2,1503.9%EUR 0.32MOther functions6,62012.0%EUR 0.99MTOTAL STUDY BUDGETEUR 18.4M
Submit proposalSubmitted
Proposal submittedRECORDED TO MEMORY · STUDY 479
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Reading your RFI...12 questions4 drafted5 have gaps3 need youPhase 1 gastroenterology studies delivered in the last five yearsClinical OperationsDraft ready
Phase 1 gastroenterology programmes since 2019, across Belgium and the
Netherlands: study count studies,
patients screened, median screen failure rate.
Drawn from 3 past proposals and your Phase 1 unit SOPsPVPieter van LoonClinical OperationsOutlookTeamsDraft attachedExport in sponsor formatS6_Torsana_RFP_selection_criteria_TOR-501-101.xlsxB12Missing: study countType the missing detailFillPVAsk Pieter van LoonSends just this gap, with the drafted answer attached
Country & Site ID
A country and site strategy only your CRO can defend.
Phase 1, gastroenterologyUnsavedDrop the protocol synopsisPDF or DOCXProtocol_TOR-501-101_v3.pdf2.4 MB1. Synopsis2. Statistical analysis planProtocol_TOR-501-101_v3.pdfsynopsis & statistical analysis planUploading 0%Counting matches...Start from a presetInvestigator strengthPI publications0.15PI citations0.25Delivery evidencePromised against delivered0.30Zero enrolling site share0.22Observed recruitment rate0.0811,221 clinical trials match
4,049 organizations match · showing top 500
Phase 1 gastroenterology · 9 countries · interventional
Reading the delivery ledger...62 shortlisted19 under-delivered7 with no enrolment recordWaalstad Medisch CentrumUtrecht, NetherlandsAcademicNo communication on recordComparable trialPromisedDeliveredPhase 2 IBD, 20242411Short by 13Phase 1 GI, 20231814Short by 4Phase 2 Crohn's, 202230--Not recordedStartup observed 118 days against a 90 day plan · evidence base 3 trials, one incompleteHeld backNo enrolment recorded against a 30 patient commitmentReserve rank 42 selectedAdd to listEnrol in workflowClearChoose a workflowCDA signatureBlinded feasibility
Pre-award Feasibility
Validate the strategy with real sites before you promise it.
← BackPre-award FeasibilityFeasibility surveySECTION 1 / 4Drop the sponsor feasibility document0 questions extractedreading the documentSection 1 // Engagement and capacity4 sections43 questions · 4 sectionsready to sendSponsor_Site_Feasibility.docx1. Engagement and capacity2. Patient accessStep 1: Initial Emailfirst contact with each organizationUse templateYendou LibraryFeasibility (Potential Investigators) [Initial Email]Feasibility questionnaire - {{study_title}}Feasibility (Potential Investigators) [FU1]Following up: feasibility questionnaireFromMara Lindqvist <mara+meridian@yendou.com>SubjectDear Full Name with Title,The purpose of this questionnaire is to assess feasibility for {{study_title}}.• Phase: {{phase}} • Therapeutic area: {{therapeutic_area}}• Target enrollment: {{patient_number}} patients • Sites: {{num_sites}}↗ Click here to complete the questionnaire: Engagement Request linkActivate feasibility outreachReportingActivities 48Output 32DashboardRecipientProgressOrganizationTask progress24 Jul 2026Task started5:54 PM, a few seconds later1 question prefilled6:09 PM, 15 minutes laterLast answer updated17 of 18 required answeredRecipientHow would you recruit the adult and adolescent patients?PtsDiff.My Pre-award Feasibility view9 charts · 4 KPIsTotal submissions32Total active patient database413Average CRC workload15.20Average active database82.60Reported patient access by siteNordbach150Silverlund100Trevaldi58CRC workload and availabilityNordbach25Silverlund20Trevaldi12Priority assigned to this protocolTop 10 priority 40%Top 3 priority 40%Lower priority 20%Primary constraints to performancePI bandwidth2Patient access1Drug logistics12 selectedExportUplift site responses to Site CRMClear
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Project delivery strategy
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Evidence based validation
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How CROs win bids
Develop the strategy. Validate it. Then make the proposal.
RFIThe gate
Qualify the CRO
0102030405
GatheredAssembled2 days back to the bid team
Search previous answers
Chase SMEs
Reconcile responses
Polish and format
Answered from your record
Only gaps routed to SMEs
Commercially polished
→Qualified to bid
Yendou RFI
RFPTen working days
Build a project delivery strategy
01020304050607080910
GatheredValidated: almost nothingValidated: most of the windowAssembled
01DevelopCountry & site intelligence
SME chaseWaitingData gatheringHow we believe it should run
02ValidatePre award feasibility
What the evidence saysWhatever can still be checked
03AssembleProposal
Whatever came backPackage
The window
OUTDay ten
What the sponsor receives
10
Delivered
Proposal
Project delivery strategy
Delivery plan
Budget
Evidence based validation
Project delivery strategy
Validated assumptions
Validated delivery plan
Validated budget
SubmittedReady for bid defence →
Award
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The site told you once. Yendou remembers forever. No portal, no login, no question they have already answered. Sites reply in days because they are not doing it twice.
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