medelis overview - a specialized oncology cro - q315

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


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


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


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


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


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

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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

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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

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David FoxVice President, Client Services

(615) 724-4004 [email protected]

medelis overview - a specialized oncology cro - q315

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