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Lupus CRO Services
Meet the challenges of lupus clinical trials head on
For the 5 million people around the world living with lupus, every therapeutic advancement matters.
With many compounds in development, drug developers are on a mission to bring new, effective treatments to patients with lupus. Getting these therapies to market requires careful planning — combined with therapeutic and operational expertise — to overcome the unique clinical development challenges presented by this unpredictable and difficult-to-treat disease.
These challenges are intensified by:
- Difficulties proving efficacy in lupus
- The need to optimize trial protocols to decrease patient and site burden
- The implementation of innovative data strategies to assess disease activity
Choosing a patient-focused provider of CRO services with the right experience, global site networks and relationships is essential to getting your lupus therapy to the patients that need it. With the PPD™ clinical research business of Thermo Fisher Scientific as your partner, you gain the expertise, resources and data quality strategies needed to advance your lupus treatment.
Our experience in lupus clinical trials
Over the past five years, drug developers have turned to us to develop strong clinical management strategies across the spectrum of lupus diseases. Our expertise in immunology, nephrology and dermatology enables us to effectively optimize lupus trial design — spanning cutaneous lupus erythematosus (CLE), systemic lupus erythematosus (SLE) and lupus nephritis (LN) — and increase the likelihood of detecting meaningful efficacy signals.
Lupus studies
CGT studies in SLE and SLE-related diseases
Patients enrolled
Lupus-experienced operations staff
Top-tier clinical trial sites
Lupus Clinical Trials Center
To enable drug developers to overcome the challenges and make the most of the opportunities in lupus clinical trials, we launched the Lupus Clinical Trials Center. This team of physician leaders, subject matter experts, operational experts and data management professionals collaborate to operationalize and deliver high-quality lupus studies for pharmaceutical sponsors.
To reflect upon the evolution of lupus clinical trials and the opportunities that lie ahead for drug developers, watch a conversation between Sudhakar Sridharan, vice president, medical and scientific strategy, and former FDA Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products Lee Simon, M.D.
They explore the history of lupus drug development, current and novel endpoints, regulatory challenges, and strategies to ensure data integrity in lupus clinical trials, including the use of proprietary data dashboards.
Recruiting the right patients for your lupus trial
Identifying and enrolling patients with the right degree of disease severity for lupus clinical trials can be a challenge. With diverse manifestations of the disease and the need for specific patient profiles, drug developers must take a targeted approach to recruitment.
We collaborate with you to decrease eligibility issues, ensuring the right patients with the right amount of disease activity are enrolled in your study. Our trained central review team has experience reviewing more than 2,300 eligibility packs in the past five years and has developed processes to deal with both complexity of issues and volume of data. This approach provides certainty around the quality of patients enrolled in the study, while improving efficiency of screening and protocol adherence.
Choosing the right sites for your lupus trial
Choosing the right sites globally has a significant impact on enrollment speed and data quality. With a network of more than 2,000 rheumatologists and over 440 top-tier clinical trial sites for lupus studies, we offer proven enrollment capabilities.
Our hands-on team will:
- Guide the selection of the right sites for your study
- Leverage existing relationships, contracts and budget specifications
- Save time and money
- Shorten startup timelines
We collaborate with Lupus Therapeutics (LT) to provide enhanced protocol and trial optimization capabilities. The collaboration combines our long-standing lupus experience with LT’s thought leadership and operational and patient advocacy expertise. Additionally, we are able to tap into LT’s preferred investigators and Lupus Clinical Investigators Network (LuCIN), which comprises more than 50 research sites with over 200 affiliated investigators, who collectively treat more than 20,000 lupus patients.
Quality data
When it comes to the monitoring of lupus data, we take a collective approach. Our team of board-certified rheumatology medical monitors, clinical trial managers, project leaders, data managers and advanced lupus efficacy review team (ALERT) have completed more than 2,300 eligibility reviews in lupus studies. Coordination between our rheumatology medical monitors, ALERT team and clinical team ensures fast and accurate reviews.
The power of technology can be leveraged to advance lupus clinical trials, using systems to improve data consistency and reduce variability, streamlining the eligibility confirmation process and electronic clinical outcome assessment (eCOA) to rapidly detect and address data issues. Our custom lupus efficacy assessment dashboard incorporates data from various sources, including electronic data capture (EDC), electronic clinical outcome assessment (eCOA) and the central laboratory, allowing efficient review of efficacy data during trial conduct.
This tool generates visualizations of BILAG, SLEDAI, CLASI, joint counts and laboratory tests, which allows data reviewers to quickly identify and query data issues. Programmed edit checks within the dashboard allow for thorough longitudinal and cross-sectional analyses by our ALERT and medical monitor teams.
Cell and gene therapy studies in lupus
The recent CAR-T therapy expansion into autoimmune diseases is expected to benefit patients, as lupus and lupus-related diseases have been the elective targets to successfully treat refractory patients. Taking advantage of CAR-T therapies for autoimmune diseases requires a deep expertise to address a variety of operational aspects such as:
- Understanding CAR-T safety profile (CRS and ICANS)
- Selecting the most appropriate investigational sites with needed accreditations (FACT/JACIE) and/or experience managing cell products
- Fostering collaboration between CAR-T experts and indication experts in patients management
- Accurately planning logistics, depending on allogeneic/autologous CAR-T
Supported by a strong collaboration with our oncology and hematology experts, the Cell and Gene Therapy Institute, and medical experts, the Lupus Clinical Trials Center provides the combined expertise and experience to operationalize and advance your CGT studies.