Immunology and Rheumatology
At the leading edge of Immunology and Rheumatology clinical research
Immunological, rheumatological and musculoskeletal diseases represent a significant burden for patients and society. PPD has extensive experience and targeted solutions to support development of programs addressing high unmet need across the disease areas. Sponsors face challenges in developing new medicines in a crowded and dynamic marketplace and PPD partners with them to guide every step along the way to delivering clear, high quality trial outcomes. This includes developing strategies to proactively address evolving needs such as diversity requirements in programs to meet FDA and EMA protocols.
PPD’s Experience In the past five years:
Clinical trials managed
Immunology and rheumatology patients
A key to our success includes access to an extensive, proven network of investigative clinical trials sites built up through our experience in this therapeutic space.
Our comprehensive immunology and rheumatology expertise spans a broad range of indications and includes advanced treatment modality including rarer rheumatology and immunology
- Hereditary Angiodema
- Lupus – Systemic and Cutaneous Lupus, Lupus Nephritis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Systemic Sclerosis
- Sjogren’s Syndrome
- Vasculidites (Giant Cell Arteritis, Behcet’s)
As immunological and rheumatology research expands treatment modalities beyond biological and targeted small molecules into mRNA technologies and cell and gene therapies, PPD is poised with extensive experience in these innovative treatment approaches. This includes a dedicated Cell & Gene Center of Excellence, which facilitates expertise-informed development of your asset no matter what technology or platform it employs.
Innovative approaches ensuring the patient is at the center
The COVID-19 pandemic accelerated development of technologies to enable digital and decentralized clinical trials, along with expectations from patients and physician communities for adopting these approaches to reduce patient burden. PPD is at the forefront of these new developments and is actively incorporating decentralized study approaches into sponsor’s Immunology and Rheumatology programs.
This includes services to enable a range of models, from a mix of in-home study and in-clinic visits (hybrid trials) to fully virtual site study. Bespoke design solutions are tailored to the specific study in hand – all with keeping the focus on the patient and reducing burden without compromising patient safety or data quality. Decentralized trials are a significant enhancement to patients with rare immunological disorders and are also finding their way into core rheumatology programs.
Understanding the importance of data quality in immunology clinical trials
Providing high quality data is core to robust clinical trial outcomes and, ultimately, regulatory dossiers supporting new drug registration. Reducing variability and ensuring the right patients are enrolled in your clinical trials is at the core of our work.
We have developed strategic partnerships with eCOA platform providers to better integrate full data inputs and facilitate patient eligibility review processes by an in-house data and medical expert team. This enables enrollment of the right target patients for your study along with dynamic, longitudinal data consistency review leading to more robust, consistent and reliable datasets.
Broad scientific and medical in-house expertise
Our team of operational experts works hand-in-hand with our team of globally distributed in-house rheumatologists to deliver superior designs, strategies and data quality.
Jerry Green, MD FACR
Senior Medical Director, Pharmacovigilance
Sudhakar Sridharan, MD
Vice President, Global Product Development
“At the end of the day, the customer isn’t really ‘buying’ the company, they are buying a connection to the people who are represented at the table. [People] want partners who are personable, very approachable, who can answer questions in a way that lets them know they understand their needs and can come up with innovative solutions—and that they do all of that with energy and dedication.”