The Indiana Clinical Trials Center has a long-standing reputation for high quality trial conduct, clear and accurate documentation, and strong recruitment numbers. We pride ourselves on building strong relationships with our sponsors and CROs through in-person meetings at AAD and Fall Clinical, honest and practical feedback on protocol design, and through excellent performance in selected studies. Because of our track record, we continue to receive study after study from sponsors and CROs we have worked with.
Why Partner With Us
CENTRAL OPERATIONS
Our trial team is under the larger umbrella of Optima Dermatology and as such, we currently have two sites – ICTC in Plainfield, Indiana, and Optima Research in Boardman, Ohio. Our goal is to continue to grow and add sites over the next several years. To accomplish this goal, we have established a central ops team to provide single-point-of-contact access to specific roles within the administrative side of trials which serve both sites from the beginning with feasibility questionnaires and site selection to the end with closing out the financials and filing termination reports.
All study opportunities are tracked through SalesForce, allowing our Leadership Team to keep a close eye on current and upcoming studies for all sites, ensuring that we have adequate staffing and supplies for every study accepted.
This streamlined approach to trial management allows sponsors and CROs to have one contact for contract and budget negotiations at all sites, providing efficient workflows, reducing redundancy, and getting sites from selection to SIV in less than 90 days.
Having a Regulatory department to oversee all studies at multiple sites allows us to minimize operational risks by monitoring protocol and ICF amendments, preventing protocol deviations, and ensuring that our clinical staff is focused primarily on the participants and their visit documentation. All regulatory documents are housed in our clinical trials management system – CRIO – which is 21 CFR Part 11 compliant. We solely work with central IRBs, eliminating the additional time and effort entangled in local IRB approvals.
Subject visits for our studies are documented through CRIO at all locations. Our centralized data entry staff can pull information from CRIO to put into EDC, ensuring that we are able to provide data within the 5-day window generally expected by sponsors, and providing a central contact for all queries from data review.
Our quality control specialist audits 20% of our visits in CRIO at each location, tracks any issues that arise, and enables us to re-educate staff and refine our processes. This auditing system decreases the number of queries from the sponsors, ensuring the most accurate data possible for studies.
EXPERIENCE
ICTC has conducted over 250 studies from Phase I-IV in a variety of conditions. We are proud of having participated in getting over 50 medications to market including many of the biggest treatments in dermatology. From topicals to orals to injectables and even infusions, we are prepared to assist sponsors with providing the best care for study subjects while collecting quality data to move investigational medications forward through the research process.
Previous study conditions include acne, actinic keratosis, allergic contact dermatitis, alopecia areata, androgenetic alopecia, asthma, atopic dermatitis, basal cell carcinoma, chronic inducible urticaria, chronic pruritus, chronic spontaneous urticaria, hidradenitis suppurativa, hyperhidrosis, ichthyosis, molluscum contagiosum, motion sickness, notalgia paresthetica, obesity, prurigo nodularis, psoriasis, rosacea, seborrheic dermatitis, vitiligo, and warts.
Our primary Principal Investigator is Scott Guenthner, MD, a board-certified dermatologist who has been conducting trials for 19 years. The PI for our allergy and asthma studies is Mitchell Smith, DO, who is board-certified in allergy and immunology as well as internal medicine.
All staff are trained and certified in GCP standards ensuring our work is conducted with quality standards, ethical treatment, and patient safety.
Each of our clinical research coordinators are IATA-certified in the lab and we have staffing levels to accommodate both blinded and unblinded pharmacists.
RECRUITMENT
It is widely known that patient enrollment is the biggest obstacle to keeping studies on their expected timeline. We pride ourselves on maintaining high enrollment standards at our site, pushing to screen patients immediately after activation, and utilizing technology to target the best patients possible.
Our patient database has over 170K patients which can be time-consuming to manually comb through for the ideal patients. Because of time constraints, our site has invested in AI technology to filter patients from our database and find the candidates that are the most likely to qualify for a study. This has resulted in more efficient workflows for our recruiters and allowed them to focus more on building a relationship with the potential patient than on manual chart review.
Because we have long-standing relationships with several trial marketing firms, we are able to strategize which firm would provide the best quality leads for specific studies based on condition, severity, and past experience. With each of these partners, we can precisely target potential candidates by age, gender, and location through social media and then adjust the demographics as needed throughout the campaign based on performance metrics.
For the last 8 years, we have sent out monthly emails to providers in the area describing the studies we are recruiting for and identifying key inclusion/exclusion criteria. We have created marketing materials that make it easy to refer patients to us and to send medical records over if needed. We also visit the provider offices each quarter, ensuring they have the materials they need, providing updated lists, and building relationships with their staff. When reviewing a study before completing a feasibility questionnaire, we analyze the inclusion/exclusion criteria for the study to ensure that we are able to find patients that would qualify, and we provide a conservative enrollment estimate to the sponsor.
CAPABILITIES & EQUIPMENT
Located in Plainfield, Indiana, in the same office as Dr. Guenthner’s dermatology practice at The Dermatology Center of Indiana, providers can easily send patients directly to the trials site for immediate prescreening.
We specialize in Phase Ib through Phase IV studies and offer seamless access to essential vendors for chest X-rays, audiology, and ophthalmology—ensuring every detail of your trial is handled with precision.
Our site contains five patient rooms and a patient lounge designed for comfort and efficiency, enabling PK draws up to eight hours post-dose and extended visits of up to ten hours. Patients enjoy amenities such as bottled water, snacks, recliners, TV, Wi-Fi, and coordinated meals throughout their stay.
The strong investment we have made in our CRIO, a 21 CRF Part 11 compliant Clinical Trial Management System, provides electronic source and regulatory documentation, remote monitoring capabilities, and an in-house stipend card system for immediate patient compensation —streamlining the research experience from start to finish.
Our CLIA certified lab is equipped with an ambient centrifuge, incubator, autoclave, -20 freezer and -70 freezer for storage of IP and lab samples. Drug storage is double-locked for safety and includes two lab-grade refrigerators and ambient storage. Unblinded IP and documents have restricted access. Our digital temperature system keeps all medications within the correct temperature range and provides 24/7 monitoring with pre‑alarm notifications if any storage zone begins to trend out of range. The generator provides backup power in case of emergency.
We have ECG equipment on site, although we prefer sponsors to provide us with their own ECG for studies when possible so that we can be efficient in scheduling and ensuring patients are here for a limited time.
Safety is our top priority. Our investigators are available 24/7, supported by a dedicated phone service to ensures patients are promptly directed to the appropriate provider. Every member of our staff is CPR certified, and our site is equipped with an AED and a comprehensive emergency kit, including epinephrine, to handle urgent situations. The nearest emergency room is located less than one mile from our facility.
POPULATION
Located just west of Indianapolis with access to urban, suburban, and rural areas, our site can recruit diverse populations based on age, gender, and race. To the west of us is a large section of rural land before getting to Terre Haute. Because here are limited dermatology options between Terre Haute and Plainfield, we get a significant number of patients from that area.
Population: 882K
Racial Diversity: 54% white, 28% black, 4% Asian, 6% other, and 8% mixed
Sex: 51% female, 49% male
Age: The median age is 34 years old. 17% of the population are over 65 years old.
Population: 190K
Racial Diversity: 80% white, 9% black, 3% Asian, 5% other, and 3% mixed
Sex: 51% female, 49% male
Age: The median age is 39 years old. 16% of the population are over 65 years old.
Population: 59K
Racial Diversity: 80% white, 9% black, 2% Asian, 7% other, 4% mixed
Sex: 50% female, 50% male
Age: The median age is 33 years old. 16% of the population are over 65 years old.