| |
 |
Therapeutic Expertise |
|
|
 |

|
|
Synarc specializes in centralized image reading, subject recruitment, and consulting services for cardiology, neurovascular, and metabolic disease areas.
To date we have participated in 75 cardiology and neurovascular multinational and multicenter studies, including 21 ongoing studies. Please join the family of satisfied Synarc clients — contact us today.
Metabolic Disorders - Diabetes
Pharmaceutical and biotechnology companies are actively researching new therapies in the area of diabetes and are seeking strong partners. Similar to other therapeutic areas, sponsors require previous experience and a strong understanding of the nuances associated with conducting diabetes trials, including a local presence and timely completion of key milestones.
The duration of the average diabetes clinical trial can be as short as 18 weeks for earlier phase trials and between 6-12 months for late stage trials. Therefore, choosing partners with scientific expertise and processes linking many aspects of the study together can be instrumental in the successful completion of the study.
There are many important aspects to consider in conducting a diabetic clinic trial. Synarc provides two of the most integral components, subject recruitment and central imaging.
Global Clinical Trials with Faster Enrollment and High Quality Data
A key to a successful clinical trial is effective and efficient subject recruitment An effective approach for sponsors to consider when recruiting for diabetes trials are Synarc’s Clinical Research Center. Synarc offers the opportunity to utilize centrally managed, multi-national investigator sites that routinely exceed enrollment and retention metrics achieved by traditional clinical sites.
These recruitment “hubs” can assist in reducing sponsors’ total drug development timeline and costs by providing a high concentration of subjects across fewer sites and retaining a high percentage of these patients for the duration of the study.
The focus of Synarc’s Clinical Research Centers is on subject recruitment, retention, compliance, and high quality performance:
- Subject recruitment:
Synarc makes it easy and convenient for people to participate in clinical studies.
Clinic staff is attentive and treat subjects courteously and professionally during each clinic visit. Centers have proven, localized recruitment strategies to fulfill subject population targets. Each center manager has a strong understanding of the communities from which they draw subjects, and work to achieve specific monthly recruitment targets from these populations.
- Retention:
It is equally important to retain subjects as it is to initially recruit them into a study. Synarc utilizes visit reminders, social gatherings, nominal gifts for holidays and birthdays as means of ensuring study participants remain connected to the site for the duration of the study.
-
Compliance:
The quality of the Clinical Research Centers are documented by FDA, EMEA, local authorities and sponsors. All clinical services are conducted according to ICH-GCP guidelines and the clinical study protocol.
- High Quality performance:
Centers are staffed by qualified physicians, study nurses, lab technicians and clinical research associates. Their clinical trial experience and expertise have a direct impact on study results.
Centers have the ability to link other aspects of the study protocol can assist further. For example, centers that are equipped to provide study procedures in-house, including ultrasound, DXA, retinal angiography, MRI, blood and urine sampling, drug storage, and pharmacy will ultimately achieve timely results.
Centralized Imaging in Diabetes Trials
Utilizing imaging endpoints in diabetic clinical trials can be extremely effective.
There are multiple imaging endpoints that can be considered in diabetic clinical trials:
| |
Diabetes/Obesity/Lipodystropy/ Peripheral Vascular Disease |
|
|
Atherosclerosis |
| |
- Quantitative Assessment of fat
- Hepatic Steatosis
- Global fat composition
- Microcirculation/ulcers
- Capillar and retinal density
- Safety Assessments
|
|
|
- IMT
- Endothelial Reactivity
- Atherosclerotic Plaque Structure
- Vascular Stenosis
- Safety Assessments
|
| |
|
|
|
|
Imaging modalities that would be utilized in diabetic clinical trials include,
- Ultrasound
- CT
- Dual-energy, x-ray absorptiometry (DXA)
- MRI
- Retinal Angiography
- Angiography
- Quantitative coronary angiography (QCA)
|
|
 |
Synarc Provides: |
- Technical consulting/protocol design and reviews
- Study documentation
- Site recommendations and selection
- Site technical initiation and site study supplies
- Ongoing image collection and pro-active tracking
- Digital data translation and film digitization
- Real time image quality control
- Reading plan design services based on FDA guidance
- Qualitative and/or quantitative review of study data
- Regulatory submission
- Successful experience with FDA audits
|
|
 |
 |
Medical Directors |
|
|
 |
|
|