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cmedresearch.com The intelligent choice for clinical trials. Oncology Immuno - oncology Cell & gene therapy Socially interactive and swims in pods of up to 100 members Can stay alert to predators by sleeping with half of its brain at a time Dolphin

The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

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Page 1: The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

cmedresearch.com

The intelligent choice for clinical trials.

Oncology

Immuno-oncology

Cell & gene therapy

Socially interactive and swims in pods of up to

100 members

Can stay alert to predators by sleeping with

half of its brain at a time

Dolphin

Page 2: The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

Cmed is an oncology focused CRO developed to fit your needs perfectly.

We are a well-established, full service CRO, with experienced people and advanced technology for clinical data management.

We specialize in applying both skills and technology to deliver well-managed trials in oncology, immuno-oncology, cell and gene therapy and other specialty therapeutics.

Our services

• Full services or functional services• Strategy, IND, Protocol design and development• Feasibility, start-up, clinical operations and monitoring• Medical, safety and PVG• Data and Analytics• encapsia - the new generation clinical data suite

Cmed is valued by biotech and pharma companies because of our:

• Flexible, responsive, proactive and collaborative approach, vital for smaller biopharma• Breadth and depth of experience in data and analytics to manage the complex data from today’s trials• Ability to provide the sites and patients needed for studies with a network of offices in USA, Western and Eastern Europe • Staff and partners in 48 countries around the world

3

Small but effective and resilient: can successfully defend its territory against much larger birds

Fast: rapid heart rate and wing speed with the highest in-flight metabolism of any bird species

Flexible, agile and highly adaptable: able to change direction almost instantly and even fly upside down

Hummingbird

cmedresearch.com

Page 3: The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

Advanced Solid Tumor (all comers) 18

Phase I Phase I/II Phase II Phase II/III Phase III Phase IV

9 32 1

17 10 21 5

Basal Cell Carcinoma 2

Acute Myeloid Leukemia 1 2

Bladder Cancer 1

Breast Cancer 5 2 9

Carcinoid Tumor 1 4

Chronic Lymphocytic Leukemia 1

Chronic Myelogenous Leukemia

Colorectal Cancer 3 2

Glioblastoma 1 1

Head and Neck Cancer 1

Liver Cancer 1

Lymphoma 1 2

Melanoma 3 2

Mesothelioma 1

Multiple Myeloma 5 4 1

Multiple Indications 2 1

Myeloproliferative Disorders 1

NSCLC 8 3 4

Ovarian Cancer 2

Other

Pancreatic Cancer

3 2 14Prostate Cancer

1

Renal Cell Carcinoma 1

1

1

Sarcoma

Squamous Cell Carcinoma 1

1 1

Advanced Solid Tumor (all comers) 18

Phase I Phase I/II Phase II Phase II/III Phase III Phase IV

9 32 1

17 10 21 5

Basal Cell Carcinoma 2

Acute Myeloid Leukemia 1 2

Bladder Cancer 1

Breast Cancer 5 2 9

Carcinoid Tumor 1 4

Chronic Lymphocytic Leukemia 1

Chronic Myelogenous Leukemia

Colorectal Cancer 3 2

Glioblastoma 1 1

Head and Neck Cancer 1

Liver Cancer 1

Lymphoma 1 2

Melanoma 3 2

Mesothelioma 1

Multiple Myeloma 5 4 1

Multiple Indications 2 1

Myeloproliferative Disorders 1

NSCLC 8 3 4

Ovarian Cancer 2

Other

Pancreatic Cancer

3 2 14Prostate Cancer

1

Renal Cell Carcinoma 1

1

1

Sarcoma

Squamous Cell Carcinoma 1

1 1

We have experience with a broad range of immunotherapies including checkpoint inhibitors, monoclonal antibodies, bispecifics, CAR-T cells, gene therapy, stem cell transplant, oncolytic viruses as well as small molecules and radiotherapies.

Our teams have experience in many additional oncology indications and therapies. Please feel free to talk with us.

Achieving success with oncology and other complex therapies requires a deeper level of understanding across multiple disciplines. As a client of Cmed you will have access to our experts with deep experience of oncology and hematology trials.

Extensive oncology expertise across medical, scientific, regulatory and operational teams

Our experience includes:

Oncology experience

Our primary therapeutic experience is in oncology and includes various hematological indications such as leukemia, lymphoma and multiple myeloma, as well as solid tumor indications including breast, lung, prostate, colorectal, glioblastoma multiforme, melanoma, ovarian and renal cell carcinoma.

Specialist expertise and experience.

25%

Clinical studies in oncology have been

in hematological cancers

75%

Clinical studies in oncology have been in a variety of solid tumours

Staff have oncology experience

100%

3,100

15,500

INVESTIGATIVESITES GLOBALLY

PATIENTS ENROLLED GLOBALLY

130+ONCOLOGY STUDIESDELIVERED

21CELL & GENETHERAPY TRIALS

10CAR-TTRIALS

PHASEI

PHASEIV

PHASE I THROUGH TO GLOBAL PHASE IV PROGRAMS

INCLUDING FIRST IN HUMAN, BASKET, ADAPTIVE AND ACCELERATED COHORTS.

4 5

Highly skilled and strategic hunter with detailed vision, silent flight and careful timing.

Owl

cmedresearch.com

COMPLEX TRIAL DESIGN

Page 4: The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

encapsia gives better visibility of all trial data to help you take quicker decisions in oncology trials.

• Live, actionable insights with real-time access to all data, including third party data• Quick to identify, query and comment on outlier data points• Immediate and complex validity checks on data points as they are recorded• eSource capability for immediate capture of subject data• Use any mix of eSource, EDC and third party data uploads within the same site or study• Rapid builds and extracts to ensure data is available for repeated interim data reviews

encapsia enables faster, better and more informed decisions in clinical trials

encapsia is a clinical data suite with clear benefits for oncology and other complex studies by providing a unique immediacy of data, insights and actions compared to traditional systems.

For example, in CAR-T cell studies where toxicity is a concern, encapsia provides immediate and sophisticated insights of data including live patient profiles plus cell and biomarker data as soon as results become available from labs. With live, interactive and actionable insights encapsia is a valuable tool to manage toxicity, helping you meet your obligations for patient safety.

Monitor and control your study with live and interactive data visualizations and dashboards.

Insights in encapsia are more than data visualizations: they are interactive and allow you to take immediate actions within the system, for example by clicking on a data point within a chart to see the relevant eCRF page.

In addition, you can highlight data, share comments and agree actions with your colleagues.

“With encapsia, we reduced project timelines by 3 weeks and facilitated dose escalation decisions by having live data access.”

International Clinical Trial Manager at a leading biopharmaceutical company, oncology study.

Disease History Timeline

Study Enrolment Dashboard - AE Subject Status

INSIGHTS

6 7

See videos of encapsia in action at encapsia.com

Page 5: The intelligent choice for clinical trials. · Dolphin. Cmed is an oncology focused CRO developed to fit your needs perfectly. ... Head and Neck Cancer 1 Liver Cancer 1 Lymphoma 1

Contact us for more information or a no-obligation meeting:

USADavid HollandDirector, Business DevelopmentT: +1 (919) 595-1121 Cell: +1 (984) 500-7970 E: [email protected]

Mickayla ReynoldsInside Sales Associate T: +1 (919) 595-6906 Sw: +1 919 595 6900 E: [email protected]

Northern EuropeLouise HollidayDirector, Business DevelopmentM: +44 (0) 7469 858056 E: [email protected]

Southern EuropeLotfi RachediSenior Director, Business DevelopmentT: +33 66 99 85 236 M: +44 (0) 7585 706 809 E: [email protected]

Rest of the worldJohn O’BrienGlobal Head of Business DevelopmentM: +49 162 337 2838 E: [email protected]

Cmed offers

• Full services or functional services• Strategy, IND, Protocol design and development• Feasibility, start-up, clinical operations and monitoring• Medical, safety and PVG• Data and Analytics• encapsia - the new generation clinical data suite

Cmed Group LtdHorsham United Kingdom T: +44 (0) 1403 755 050

Cmed Inc Morrisville, NC 27560United States T: +1 919 595 6900

Cmed Inc Cambridge, MA 02139 United States T: +1 617 947 6681

Cmed Inc San Bruno, CA 94066 United States T: +1 650 616 4291

Cmed SRL Timisoara, 300011 Romania T: +40 356 43 39 20

cmedresearch.com Email: [email protected]

“Compliments go out to the team, your organization allows for a hassle free experience every time. It is great to have such a strong relationship with a fully trusted partner, thank you for all your help and expertise. Looking forward to working with you through the last year of the trial and into the future.”

Sponsor, Global Trial Program Director at a top 5 pharma company, oncology study.

oncol-05-20

19oncol-0

5-2019