Elligo Design Services Lookbook

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DESIGN SERVICES

Lookbook

Partners in Success

Contents.

We are design specialists.

Working closely with our clients to strategize campaigns, ClinEdge targets your patient population. We draw from our extensive experience in developing marketing campaigns and brand strategy in order to help your trial exceed enrollment goals.

We Visualize the Success of Your Clinical Trial.

Patient Recruitment Creative for Sponsors

Whether it’s creating a unique study brand, designing patient materials, or developing a study website, ClinEdge’s design team understands how to relate to the patient community through creative, impactful design. We can adapt materials to meet country specific needs on a global scale such as language translations and cultural adaptations.

Branding.

Positive Impression + Unique Design = Brand Success.

OUR BRANDING PACKAGE FEATURES:

Name Development

Consistent & Recognizable

Optimized for Audience

Differentiation from Competitors

Patient-Friendly Brand Perception

Brand Stories that Build Lasting Patient Relationships

All study related medications, office visits and examinations are free

How are my rights and safety protected as a patient during a clinical trial?

Protecting the health and safety of people who take part in clinical trials is the highest priority for clinical researchers throughout the entire study process. All clinical trials follow strict federal guidelines on how volunteers must be treated.

Take control of

future of influenza therapy

Dial Down

CANCER PAIN

For the Dial Down Cancer Pain Trial we were scoped to design and manage the study website, online advertising campaigns, and collateral designs.

The brand featured bold, striking colors meant to evoke a strong, active response from the potential patient. The ads were high-contrast, eye-catching, and helped to convey the goal of the study; researching a therapy to reduce cancer-induced pain.

FREQUENTLY ASKED QUESTIONS

What is a clinical study?

A clinical study tests an investigational medication or treatment in a population of qualified volunteers. All new drugs or medical treatments and devices must go through the clinical study process, so participants like you play a very important role to help further medical care and treatment of NFPA for present and future generations.

An NFPA is a pi uitary tumor that is characterized by the absence of clinical or biochemical tumor-related hormone excess. Because they are clinically silent, these tumors often present as large masses that cause clinical symptoms due to mass effect on critical nearby structures causing hypopituitarism, visual defects and cranial nerve palsies.

NON-FUNCTIONING PITUITARY ADENOMA

How are my rights and safety protected as a patient during a clinical study?

Non-Functioning Pituitary Adenoma or NFPAs are tumors that form in and around the pituitary gland.

Protecting the rights, wellbeing, and safety of clinical study patients is a top priority for clinical researchers and physicians throughout the clinical study process. Clinical studies follow strict federal guidelines regarding the treatment of volunteers, and all processes and materials must be investigated by an independent ethics committee called the Institutional Review Board (IRB). All aspects of the study will be explained to you by the study personnel, and you will have the opportunity to ask questions or voice concerns.

How does a clinical study evaluate an investigational medicine?

Clinical studies have a structured process for visits, medical assessments, and a dosing schedule the patient must follow. Information about how you feel and how you are reacting to the study treatment is collected.

Can I leave the clinical study before it ends?

WELCOME TO THE Lightbeam Study!

A Phase 2 clinical trial investigating the safety and tolerability of an investigational medication in adult patients with a non-functioning pituitary adenoma (NFPA).

The standard of care therapy is transsphenoidal surgery (TSS) to allow decompression of tumor. However, given the location of these tumors, complete surgical resection may be limited by other local anatomical structures, causing many patients to have residual tumor remnants post-surgery, which can continue to grow after surgery. Repeat surgery or radiation therapy may be required, which carries increased risk to the patient.

Do I Qualify?

Qualified participants must:

• Be between the ages of 18-80 years old with a confirmed diagnosis of NFPA

• Be on a stable dose of hormone replacement therapy

• Have not undergone radiation therapy to the head

• Have not had more than one transsphenoidal surgery (TSS)

• Have no history of psychotic disorder

• Have no allergies to contrast dye

• Have no history of uncontrolled diabetes

THIS STUDY

IS SPONSORED BY: [SITE

Clinical Research Study for Patients with Non-Functioning Pituitary Adenoma (NFPA)

Consider participating in a clinical research trial and help to advance medical options for patients with NFPA.

Tiburio_TBR-760-NFPA-201_Brochure_EN-US_Version 1_FINAL_03 Sept 2019

lightbeam

© 2021 Elligo Health Research, Inc. All rights reserved. Confidential information of Elligo Health Research, Inc. 14

PATIENT DOSING DIARY

Frequently Asked Questions

Website Designs

What is a clinical study?

A clinical study tests an investigational medication or treatment in a population of qualified volunteers. All new drugs or medical treatments and devices must go through the clinical study process, so participants like you play a very important role to help further medical care and treatment of NFPA for present and future generations.

How are my rights and safety protected as a patient during a clinical study?

Protecting the rights wellbeing, and safety of clinical study patients is a top priority for clinical researchers and physicians throughout the clinical study process. Clinical studies follow strict guidelines regarding the treatment of volunteers, and all processes and materials must be investigated by an independent ethics committee. All aspects of the study will be explained to you by the study personnel, and you will have the opportunity to ask questions or voice concerns.

How does a clinical study evaluate an investigational medicine?

Clinical studies have a structured process for visits, medical assessments, and a dosing schedule the patient must follow. Information about how you feel and how you are reacting to the study treatment is collected.

Can I leave the clinical study before it ends?

You have the right to leave a clinical study at any time. If you decide to leave, talk to your doctor first. You will want to know how leaving the study might affect your health.

Recruitment Materials.

Tailor. Target. Recruit.

OUR RECRUITMENT MATERIAL FEATURES:

Engaging Designs

Traditional Print Collateral

Digital Materials

Tailored Message to Your Audience

Mandatory IRB Details

Brand Stories that Build Lasting Patient Relationships

Dog Elbow Pain

ARTHRITIS IN CANINES

This recruitment video was one of several featured through our Facebook advertising efforts. Each video is tracked to see which performs the best. Our marketing team then is able to push the most engaging videos to the right audience, at the right time, on the right platforms.

VE303-002- Physician Letter_V4.0_26Sep2019

Dear Colleague, wanted to share some information about The CONSORTIUM clinical study, sponsored by Vedanta Biosciences, as it may be of interest to you and to some of your patients.

This study is testing the safety and effectiveness of an experimental drug called VE303 compared to a placebo (a capsule containing no VE303), for the prevention of recurrent C. difficile infections. VE303 is a preparation of eight different types of bacteria that are grown in clean conditions, dried, powdered and put into capsules. The bacteria are activated once they reach the intestines. VE303 is manufactured from clonal cell banks of pure, uniform compositions, bypassing the need to rely on fecal transplants direct sourcing of fecal donor material of inconsistent composition, and in some cases unknown safety. The study drug is administered orally for 14 days. VE303 is being studied to see if it can help get patients’ intestinal bacteria back to a healthy state after an episode of CDI, and potentially reduce the chance of CDI from returning.

Welcome

Thank you for participating in the CONSORTIUM study for rCDI. This brochure should help you understand your participation requirements for the clinical trial.

Preclinical data and a previous study in healthy volunteers suggest that VE303 may help reestablish resistance against C. diff by accelerating restoration of the gut microbiota from damage caused by antibiotics. The safety study of VE303, showed that the doses used in that study were safe and well tolerated in healthy volunteers.

TO

BE ELIGIBLE FOR THIS STUDY, A PATIENT MUST*:

DURATION

duration of this study is approximately 7 months. You come for 7 scheduled visits at the clinic, and contacted by phone (during the 14-day dosing (except for visit days) and at Week 12, Week 16 and

THE STUDY

WHAT WILL I HAVE TO DO?

When you are in a medical research study, you are expected to come to all your study visits and to follow the instructions given to you by your study doctor and study research team.

• You must let your study doctor know of any changes in your health while you are in this study.

Have an active episode of CDI, have not been on antibiotic treatment for more than 72 hours and fall into 1 of these 3 categories:

o At least 18 years of age and have experienced a prior episode of CDI within the last 6 months

o Between the ages of 65 and 74 (inclusive) with or without prior episodes of CDI who exhibit one or more of the following risk factors for recurrence:

o Have kidney dysfunction, defined as creatinine clearance of <60mL/min/1.73m2 at the time of the current CDI episode;

Please refer to your study dosing diary and instructions throughout this clinical trial.

is testing the safety and effectiveness of an experimental drug, known as VE303, and its ability to from returning. VE303 is a preparation of different bacteria which were selected for their ability to prevent the regrowth of C. Difficile. selected bacteria are grown in clean controlled dried, powdered and put into capsules for oral administration where the bacteria become reactivated reach the intestines. VE303 is manufactured cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria contrast with fecal transplants, which rely on sourcing of fecal donor material of inconsistent composition.

experimental drug is a drug that has been approved and Drug Administration (FDA) to be tested population of volunteers. Preclinical data previous study in healthy volunteers suggest that help reestablish resistance against C. diff accelerating restoration of the gut microbiota from caused by antibiotics. The safety study of VE303, that the doses we are using in this study were well tolerated in healthy volunteers.

• You should check with the study doctor before starting to take any new medications or remedies.

• If you or your partner becomes pregnant, you must notify your study doctor immediately.

• If you choose to stop your participation in the study for any reason, you must notify your study doctor imme diately so that a plan can be made for your continued medical care.

• You will be expected to return to the clinic for your final study visit.

THIS

STUDY IS SPONSORED BY:

• Please do not give blood for non-study purposes, unless medically required, while you are taking part in this study. STUDY

Welcome

o Have a history of regular use of proton pump inhibitors (PPI) such as omeprazole, pantoprazole, etc. within the past 2 months and will be continuing use of PPIs throughout the study;

o Have a history of CDI at any time;

o At least 75 years of age and are experiencing an active episode of CDI

All study-related visits, tests, and study medications will be provided to participants at no cost.

Please know that I will only see your patients within the context of this study. For any medical concerns outside this study, your patients will be directed back to you. If you are interested in learning more about this study, or would like to refer a patient, please contact at _

Thank you for your time and appreciate any consideration and support you might provide for this important research.

Sincerely,

*Additional study requirements apply.

CONSORTIUM

RECURRING CLOSTRIDIUM DIFFICILE INFECTION

Branding

Recruitment Materials

Website Designs

The CONSORTIUM clinical study included recruitment and retention materials to help patients and physicians navigate through the study. Materials included: recruitment flyers and brochures, welcome brochure, visit calendar, appointment cards, collection instructions, and physician letters. Recruitment packets and additional supplies were fulfilled and shipped to sites upon activation and on an as-needed basis.

The Reflect Study was a full brand development project that included naming, logo design, website and collateral pieces. The name “reflect” was inspired by the reflective nature of water, as many patients with this skin condition use water to sooth their symptoms. The imagery chosen for the brand included watercolor marks and photography of lakes, with abstracted portraits and reflections.

Testing the safety and effectiveness of a topical cream for adults and adolescents living with Ichthyosis.

The Reflect Study is testing the safety and effectiveness of a topical cream for adults and adolescents living with Lamellar Ichthyosis (LI). This investigational cream is applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. The Reflect Study aims to help improve symptoms of LI for current and future generations.

THOSE WHO QUALIFY FOR STUDY PARTICIPATION CAN EXPECT THE FOLLOWING:

Study Duration: 12 weeks, with the option to continue for another 12 weeks (up to 24 weeks)

Treatment Received:

All study participants will randomly receive either the study medication with the active ingredient or placebo for the first 12 weeks (2/3 likelihood of receiving study medication with active ingredient). Those study participants who complete the first 12 weeks of the study and wish to continue for another 12 weeks will receive study medication with the active ingredient (no one will receive placebo).

Treatment Frequency: Twice weekly.

YOU MAY QUALIFY FOR THE REFLECT STUDY IF YOU:

• Are 12 years of age or older

• Have been Diagnosed with Lamellar Ichthyosis

• Have Moderate to Severe Lamellar Ichthyosis

SEE IF YOU QUALIFY

Additional study details, frequently asked questions, and contact information are available on the study website:

ICHTHYOSISSTUDY.COM

PROSHIP PROSTATITIS

Branding Recruitment Materials

For the PROSHIP Study for Prostatitis we focused on a bold geometric logo design that translated into the rest of the study materials. Items created included online ads, patient collateral and physician brochures to help display study information. The strong royal blue and deep green color scheme was pulled through the study materials creating a cohesive and recognizable brand.

Website Designs

Dreambird ACHONDROPLASIA

The Dreambird Study was branded with a fun, light-hearted and whimsical approach. A unique set of bird characters were designed each with their own style and personality. These were turned into actual custom stuffed toys given to the children participating in the clinical study. The goal of the branding was to offer a unique, positive and creative design to all materials so the children around the world participating could relate and feel involved. The children had several visits and milestones to reach within the trial so the set of birds were given over a period of time. Certificates were also handed to children during those visit milestones.

impac

PERSISTENT ASTHMA IN CHILDREN

For a pediatric asthma study, the ClinEdge design team developed a logo and mascot that was friendly and eye-catching for the young patient population and their caregivers. The mascot was used on all of the study materials, ranging from recruitment items such as posters and informational brochures, to the patient-facing activity books and stickers used in the duration of the study. Throughout their participation, patients were required to stay at the study site for long periods of time. The ClinEdge design team created activity baskets consisting of study branded iPads, crayons, stickers, dominoes and puzzles to keep the patients engaged during these long visits.

Website Design.

Sleek, functional, and informative websites built for clinical research.

OUR WEBSITES FEATURES:

GDPR Compliant

Responsive & Mobile Friendly

Optimized for Speed

Integrate Seamlessly with Secure CMS System

Patient-Friendly Language

Password Protected Pages for Enrolled Patients or Physicians

AQUAx XEROSTOMIA (DRY MOUTH)

Branding Recruitment Materials Website Designs

The AQUAx study website for dry mouth focused on a simplistic graphic approach instead of using photography or other imagery. The light blue color palette matched the client’s corporate brand and also played well with the water-focused “wet” theme of the branding. This one-page web design included high-level study information and a simple contact form for patients to submit inquiries.

Lavender + Lilac Study

Rett Syndrome is a neurodevelopmental disorder that occurs primarily in female children. A range of websites were created in this project, some of which are shown here. The Phase 3 Lavender Study is followed by the Lilac Study, an open label extension study, therefore both logos were used in the design of this landing page. The bright imagery and soothing tones of lilac and lavender shades connect back to the study names and overall brand.

Website Designs

RETT SYNDROME

Momentum MYELOFIBROSIS

The MOMENTUM Clinical Trial for Myelofibrosis focused on a color palette with high contrast, along with a circular pattern theme used throughout the design. The website is highlyinformative, easy to navigate, and includes translations for over 20 languages.

NON-SMALL CELL LUNG CANCER

We took a nautical approach for the overall theme of this study to pair with the coastline-inspired logo. For imagery we edited photographs to appear as watercolor paintings, and used bright blues throughout the design sections. The color scheme matched the Sponsor’s corporate branding and coastal location, creating brand continuity and recognition.

Branding Recruitment Materials

Website Designs

pheNIX

PHENYLKETONURIA

ClinEdge designed a website for a gene therapy study for Phenylketonuria (PKU) - an inherited condition caused by a defect in the PAH gene. The design focused on a bright, clean and simple aesthetic that matched the helix elements found in the study logo. The website also includes passwordprotected pages for Physicians and Enrolled Participants to share even more information about the study through the website platform.