Site Profile Summary and Capabilities
As a dedicated research facility, Renstar Medical Research has maintained a reputation of commitment and dedication to our Sponsors and community through a transparent, systematic approach to clinical research with our multi-specialty team of board certified physicians and trained staff.
Areas of Specialty:
- Neurology and Movement Disorders. This includes, but not limited to, Mild Cognitive Impairment, Alzheimer’s Disease, Parkinson’s Disease, Multiple Sclerosis, Neuropathy and Migraine Headaches. Within this area, our experience ranges from oral therapy to monoclonal immunotherapy and genetic testing in small Phase I through large-scale Phase III trial.
- Dermatology. Our primary focus within this area is development of biological and biological biosimilar therapies for plaque psoriasis. Our dermatologists and clinical staff have experience in therapies for acne, rosacea, actinic keratosis and atopic dermatitis, including bioequivalence trials. We have the capability to participate in cosmetic or dermatology device trials along with other emerging areas within dermatology.
- Chronic Pain, Rheumatology and Inflammatory Illnesses. Chronic pain can be difficult to treat, and many of the available therapies do not adequately treat pain associated with fibromyalgia, osteoarthritis, rheumatoid arthritis or neuropathic pain. In part due to our location and overall population demographics, we have access to a larger pool of patients interested and seeking out clinical trials within this therapeutic area.
- Sleep Disorders. Not only do we have a fully-equipped unit allowing for overnight confinement, we work with two local, accredited sleep laboratories overseen by board certified physicians in sleep medicine with certified, trained technologists using the latest equipment for sleep studies.
- Healthy Volunteers. From Phase I through post-marketing trials, we actively participate in healthy volunteer trials, including but not limited to, memory recall, memory decline, devices, and nutrition or other supplements.
- Endocrinology and Metabolic Disorders. We have much experience in trials for the management and treatment of diabetes and disorders associated with diabetes. This includes trials in obesity for individuals with or without diabetes along with nutrition and dietary counseling.
- Respiratory. Our pulmonology Investigators specialize in the treatment of respiratory conditions such as Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Hypertension along with other respiratory illnesses.
- Urology. This area affects both men and women across a large age spectrum. Our experience within the area of urology, includes but is not limited to, overactive bladder, benign prostatic hyperplasia, erectile dysfunction and other men’s health conditions and prostate cancer.
- Internal Medicine and General Family Practice. Our experience in this area crosses many therapeutic lines for treatments in gastroenterology such as erosive esophagitis and GERD to treatment for illnesses like high cholesterol, hypertension and other lipid disorders.
- Psychiatry. Primarily, our experience in psychiatry is purposely limited to Major Depression Disorder and Generalized Anxiety. However, our experienced psychiatric Investigators along with mental health professionals are proficient in conducting a wide range of psychiatric assessments commonly found in clinical trials.
- Ophthalmology – Our Ophthalmology Investigator specializes in Cataract Surgery and the treatment of Glaucoma.
On-Site Facilities and Equipment
Phase I and Early Phase Trial Clinic. We participate in small phase I, phase I/first-in-man, early phase and pharmacokinetic trials that require extended or overnight confinement in our facility. Our unit is equipped with the following:
- 10-bed capacity
- On-site pharmacy
- Laboratory processing area with equipment, such as, ambient and refrigerated centrifuges, Quantiferon incubators and necessary safety equipment and supplies for processing of lab specimens
- IV Pumps and associated supplies
- Three-Channel ECG with optional interpretation
- Digital weight scale with accuracy to the nearest 0.2 lbs and standard height and weight Equipment
- Ambulatory blood pressure machines
- Locked -20⁰ and -70⁰C freezers with web-based, NIST certified continuous temperature and humidity monitoring system
- Locked investigational product storage for ambient and refrigerated products with web-based, NIST certified continuous temperature and humidity monitoring system
- Handicapped accessible bathroom and shower facilities
- Dining and lounge area including TV/DVD and Patient Wi-Fi Access
- Kitchen facilities for food preparation
Facility Safety Equipment and Procedures
- Crash Cart meeting ACLS Criteria, including medications, defibrillator and oxygen and IV supplies
- ACLS certified research personnel and/or emergency medical personnel present during entire patient confinement
- Located within 5 minutes of two hospitals with emergency room facilities
- Personnel trained on Renstar’s standard operating procedures for emergency and medically urgent events.
- Back-Up generator power and processes for emergency and power outages.
Dedicated Clinical Trial Monitoring Area
- Accommodate up to 5 Sponsor and/or CRO monitors each day with each monitor having his or her own dedicated area. This allows for appropriate work space for monitoring regulatory and clinical documents while building in additional precautions for the protection of confidential and protected health information.
- The area is equipped with dedicated copy and fax capabilities and both wireless and cable internet service.
Off-Site Equipment and Facilities
- Imaging. Renstar has a long-standing professional relationship with a local imaging facility with dedicated technologists with clinical research training and experience. The licensed, imaging personnel and on-site radiologist have been certified by industry’s top central imaging groups to perform specific roles in the trials.
- X-ray
- High-field MRI
- PET with experience using various amyloid tracing materials
- Digital mammography and CAD
- Ultrasound with color doppler
- Bone densitometry
- Multi-slice CT scanner
- Fluoroscopy
- Pulmonology
- Pulmonary function testing
- Cardio-pulmonary exercise testing
- Gastroenterology
- Colonoscopy
- Endoscopy
- Urology
- Urinary flow
- Prostate ultrasound
Process-Driven Approach to Clinical Research
Renstar Medical Research takes a process-driven approach to each area involved in the execution of a clinical trial. This approach has proven effective from trial procurement to the final closing of a trial.
Trial Procurement, Clinical and Logistical Protocol Feasibility and Trial Initiation Processes
Renstar has trained staff to seek out appropriate trials and perform all trial feasibility processes. This dedicated team is led by the project management team and is focused on rapid turnaround on trial feasibilities, questionnaires, and protocol reviews for both pre-award and awarded clinical trials. Upon receipt of a trial synopsis or protocol, both clinical and project management perform pre-feasibilities in the early stages and in-depth feasibilities later on in the trial selection phase. The feasibilities focus on availability of the patient population, patient burden, logistics and execution, similarity to standard of care, recruitment, enrollment and retention rates. The outcome of these additional steps of internal collaboration affords us the ability to make definitive decisions on our site’s ability to properly execute the trial and exceed ours and our Sponsor’s expectations. The feasibility process is one of the most important processes in our successful participation in clinical trials and sets our site apart from others because our goal is to be involved in only trials that fit our site’s population, purpose and goals.
Regulatory Processes
Our dedicated regulatory department has over 35 years combined to bring a higher level of regulatory compliance and created processes that dramatically decrease regulatory delays and increase response time.
- Use of Sponsor-Designated Central Internal Review Boards
- Streamlined internal process of completing and submitting initial regulatory packets with an expected turnaround time of less than one week.
- Ensure all staff maintain current Good Clinical Practice training and IATA certifications bi-annually and maintain training documentation on all staff
- Work one-on-one with Sponsor and/or CRO representatives during their monitoring visits to address any issues and answer any regulatory queries. This dedicated approach allows for an efficient and effective monitoring visit for both the Sponsor and the site.
- Expedited processes for maintaining or obtaining approvals and dispersing of protocol amendments, Informed Consent Forms and other regulatory or Sponsor directed communication.
- Documented reviews of safety reports and safety letters
- Consistent, documented communication with Internal Review Boards
- Maintenance of Investigator Site File
Data Management, Quality Assurance and Quality Control
Renstar Medical Research employs both a multi-tiered quality assurance (QA) and separate quality control (QC) approach to data management. The rationale is to provide a series of checks and balances to ensure enrollment of appropriate study volunteers, protocol compliance and the ability to provide clean data within the Sponsor’s data timelines. Data reviews performed by our dedicated QA specialists, the study coordinator, and a third party internal quality control reviewer have proven effective in eliminating corrections and deviations during our routine monitoring visits and routine audits.
As with our regulatory department, our QA and QC Data Management team follow strict processes to perform effectively and maintain data integrity. Some of these processes are outlined below:
- Entry of data obtained during each study visit meeting the Sponsor’s timelines
- Resolution of data queries
- Review of all source documents, lab reports, assessments to ensure all study visit procedures are completed and documented
- Prompt processing of medical records requests and additional clinical reviews of all medical records received
- Identifying unanticipated issues within the protocol or execution of study procedures
- Independent review and reconciliation of patient-reported medical history, patient discussions and physician documented medical records to establish the most accurate medical history for purposes of patient safety and appropriate enrollment
- Working one-on-one with Sponsor and/or CRO representatives during their monitoring visits to address data issues, resolve queries and maintain clean study documentation. This, again, increases the efficiency of a monitoring visit and requiring less on-site time for Sponsor and/or CRO representatives.
- Ongoing auditing of trials in an effort to remain “audit ready”
Trial Recruitment
Prior to the initiation of the clinical trial, our project management, clinical team, and dedicated recruitment department work together to establish an appropriate recruitment plan. As all trials are different, the recruitment plan of each trial will have various nuances that must be addressed. The recruitment plan is established based on the protocol-specific criteria, knowledge of the trial-specific patient population, past metrics of successful plans and methods to reach the target population.
During this time, the following steps are performed:
- Creation and IRB approval of telephone screening script
- Pre-Screening and chart review of Investigator’s database
- Review of the nearly 15,000 individuals within our research database
- Discussions with other local physicians or Investigators about the upcoming trial
- Development of recruitment materials that may be needed to boost enrollment. Recruitment materials are based on the target population and may include social media campaigns, print, radio or newspaper advertising.
- Development of recruitment plan that may involve free health screenings, educational seminars, physician lunch and learns, and community events.
Because of efforts prior to the initiation of the trial, our site is consistently one of the first sites to screen and enroll trial participants. Additionally, our staff is better prepared with potential solutions if unexpected recruitment obstacles arise.
Trial Retention
Overall, our site maintains less than a 2% drop-out rate of enrolled individuals during the course of the trial. The primary reasons for such a high retention rate are the methods employed during the recruitment period, screening the most appropriate individuals, and ensuring enrollment of only protocol-qualified subjects. Combining these efforts with a patient-centered Investigator and clinical staff focused on the individual creates an environment in which the individual is dedicated to his or her participation in the trial.
In-House Project Management
Renstar takes a unique approach to trial execution through the use of an in-house project management team. This experienced team works closely with the Investigator, clinical staff, recruitment, regulatory, and data management staff in the very early stages of protocol feasibility and study team selection through the completion of the trial. Project Management often acts as an in-house liaison between the Sponsor and/or CRO and the site by assisting the Investigator and staff with changes within the protocol, identifying and resolving issues that often arise during the course of a trial, assist with planning, enrollment and retention methods, and the overall progress of the trial. The project management team meets multiple times each month and executes necessary changes at the site level, for example, revising the recruitment plan or implementing new outreach methods. The addition of a project management team working closely with each department has proven effective in the overall effectiveness of our site in each area of clinical research.
