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A SPECIALTY CROfor Phase I – III oncology trialsClinical answers, faster.Clinical answers, faster.
www.medelis.com
www.medelis.com 2
Overview
05/03/2023
Medelis is a specialty oncology CRO that takes pride in building strong relationships with our clients.
Founded in 2003 by a group of experienced clinical research oncologists like Dan Von Hoff and Michael Gordon, we deliver oncology expertise at the strategic and tactical level – from protocol development and regulatory guidance to site management and medical writing.
www.medelis.com 3
Expert Guidance
05/03/2023
Board members are actively involved with our study team providing expertise in:
Study designSite selectionPatient populationsThe latest trends and ideas in oncology drug developmentRegulatory guidance through FDA and EMA
Strategic expertise… available when needed.
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Operational Oncology Expertise
05/03/2023
Oncology trials are complex. You need an entire team of qualified experts that knows how to handle the intricacies that arise during an oncology clinical trial.
We are not a training ground for people just starting in clinical research, or even oncology.
All of our operational resources are highly experienced and have proven experience in oncology studies.
www.medelis.com
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Experience Quantified
05/03/2023 www.medelis.com
All clinical operations team members haveat least 10 yearsof hands-on experience managing clinical trials15 yearsaverage length of experience
Our clinical operations team has managed over 425clinical trials
over 200oncology studies
are nurses with oncology training (and many are former oncology study coordinators)
are physicians and former investigators with hands-on research experience in managing and evaluating safety in clinical trials
80% of CRAs Our medical monitors
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Operational Approach
05/03/2023 www.medelis.com
Dedicated project manager for the entire duration of your trial
Act as a true extension of your team
Flexibility to adapt to and integrate into your team, processes and systems
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Operational Approach
05/03/2023 www.medelis.com
Relationships are our #1 priority
Our client’s success is our primary focus - partnerships breed success
We're not the large CRO that cycles people through trials and foregoes developing relationships
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Bid Philosophy
05/03/2023 www.medelis.com
We don’t provide a lowball bid… and then create change orders throughout the trial
We bid on the units and services necessary for the success of your trial
We won’t submit a change order unless you change the scope of the trial
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What This Means for You
05/03/2023 www.medelis.com
Deep oncology experience at each level of your trial
A dedicated project manager
Cost certainty… and unit pricing enables you to quantify costs should study assumptions change
A proactive and innovative team that anticipates challenges and presents solutions
A flexible approach… for those times when your goals change midstream
Flexible billing
Cost savings via fixed price, time and materials, unit costs, low overhead, billing only direct personnel… and no change orders
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Services
05/03/2023
Sponsor CommunicationStudy CoordinationManage Trial Status ReportsTimelinesBudgetsTrainingInvestigator MeetingsResource ManagementVendor/Provider ManagementInvestigator Grant ManagementTrial Master FilePatient RegistrationNegotiate Investigator Contract & Budgets
Develop Data Monitoring Plan Conduct Site TrainingSite ManagementMonitor Subject EnrollmentManage Site Communication and Trial Related IssuesConduct Interim Monitoring VisitsEvaluate Patient EligibilityAdverse Event MonitoringMonitor Drug AccountabilityTrial ClosureGCP Quality ProcessSite Payment Admin
FeasibilityInvestigator IdentificationSite Qualification VisitsRegulatory Document Collection and ReviewBudget NegotiationsContract Negotiations
Evaluate Patient EligibilityTherapeutic Training of TeamMonitor Patient SafetyPeriodic Coding Review 24/7 Medical CoverageData Monitoring CommitteesDevelop Safety PlanSAE ReportingIND Safety Alerts
Project Management
Site Management & Monitoring Study Start-up Medical Monitoring
& Safety
Quality Management
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Services
05/03/2023 www.medelis.com
Review and reconciliation of complex data: PK, biomarkers, imaging and other lab dataSAE reconciliationClinical review of patient profilesNarrative reviewReview of endpoint assessmentStatistical output reviewProtocol deviation review
Sample size calculationsRandomization schemesStudy Design and protocol developmentStatistical analysis planStatistical programming using SASStatistical analysisStatistical reportsStatistical consultingStatistical representation at FDA meetings
EDC services provided using Phase Forward’s Inform EDC platformDatabase buildeCRF developmentEdit check programmingMaster user list setupPortal setupUser trainingIRT integrationClinical data managementEDC developers have built >35 trialsCDMs average >10 years industry experience
Protocol developmentInvestigator’s BrochuresInformed ConsentsClinical Study ReportsSAE NarrativesAnnual ReportsINDs and other regulatory documents
Expert Clinical Data Review Biostatistics Data
Management Medical Writing
Quality Management
www.medelis.com 12
Experience
05/03/2023
Deep experience managing Phase I through Phase IIIs in the United States and Europe
Public & PrivateBiotech & PharmaceuticalLarge & Small GovernmentalAcademic & Institutional
Full service or a la carte project based-work
Experience in almost every oncology indication
Specialization in complex studies
www.medelis.com 13
Company
05/03/2023
Boston, MANashville, TN
European HQ - France
Founded in 2003 by experienced oncology clinical research physicians
Full service or a la carte, for phase I through phase III oncology trials in US and Europe
Highly experienced oncology team members and consultants
Solution providers for design and implementation of innovative, complex oncology clinical trials
05/03/2023 www.medelis.com 14
David FoxVice President, Client Services
(615) 724-4004 [email protected]