Even though there are now many approved multiple sclerosis (MS) treatments, patients still have significant unmet needs. Within this complex competitive landscape, customers often struggle to position and differentiate their compounds to engage sites and patients. Our MS team members and neurologists not only know how to navigate these trials, but they also understand how to favorably position your compound considering a nuanced understanding of competitive strengths and weaknesses such as side effect profiles and routes of administration.
Within the neuroinflammatory group, we also have experience in a range of rare diseases such as neuromyelitis optica (NMO) and chronic inflammatory demyelinating polyneuropathy (CIDP) where we combine our therapeutic expertise with our rare disease acumen.
Developing strategies for Alzheimer’s disease/dementia studies can be challenging, given their high rates of failure. PPD has supported over 20 studies in the past five years. We have developed novel approaches including clinical trial simulation to optimize trial design and predict results, accelerated enrollment solutions like the Synexus HealthyMinds Registry to increase the pool of potential study candidates, and digital offerings to reduce patient burden and minimize trial disruption. We offer full development solutions and experienced study teams, including leading industry-leading early phase clinical research units and a global network of quick-start sites all focused on neurodegenerative disorders.
PPD has conducted full service movement disorder trials, including gene therapy studies. Our experts in movement disorders recognize the tremendous advancements and momentum in this therapeutic area, particularly in Parkinson’s and related indications. Our global Parkinson’s disease experience includes studies conducted in the past five years across various phases in a broad spectrum of populations ranging from early to advanced Parkinson’s and including gene mutation populations.
More than half of studies in pain indications fail because the outcomes do not distinguish placebo from active drug responses. We have developed a robust process for placebo response mitigation that helps produce clearer data outcomes by using operational controls, which subsequently help form a better picture of placebo versus drug response.
Our relationships with experienced clinical trial investigators result in quicker study startup. Our use of a variety of clinical technologies – electronic data collection (EDC), electronic case report forms (CRFs) and handheld diaries, interactive voice response (IVR) and interactive web response (IWR) – allows for rapid retrieval and analysis of data for single country or global studies. We have also developed streamlined processes to allow integration of multiple systems to minimize data duplication and ease the burden on sites and subjects for data entry.
Our experience includes acute pain, chronic pain, neuropathic pain and migraine pain.
Psychiatry & Neurobehavioral Disorders
Psychiatric studies bring a unique set of challenges, including subjective assessments, inter-rater reliability, scale validation and placebo response rates. Over the past five years, we have conducted studies in indications ranging from schizophrenia to anxiety, expertly overseeing global programs of all sizes. We offer our customers access to a strong network of qualified global resources, including our global investigator database of psychiatrists, neurologists, neurological surgeons, and gerontologists.
We offer a clinical operations and therapeutic focus on ophthalmology studies with dedicated project teams. Our professionals are experts in facilitating multinational submissions and expeditious agency reviews and have global experience in age-related macular degeneration, conjunctivitis, dry eye, glaucoma, keratitis, lens opacification and intraocular lenses (IOLs), diabetic macular edema, retinal vein occlusion and geographic atrophy.
The execution of any rare disease trial requires different skill sets. This is especially true when a rare disease crosses with neuroscience indications. We attack the challenges of these trials head on by embedding specialized and flexible development strategies that includes rigorous assessment of feasibility, robust training and supportive relationships with sites, collaboration with patient advocacy groups, patient concierge services and more.
We have refined our approaches to rare disease research having participated in many that were in neuroscience indications in areas as diverse as Duchenne muscular dystrophy (DMD), Huntington’s disease, retinopathy of prematurity, and more. We assign dedicated therapeutic area leads to oversee rare disease studies so that customers get the best of both worlds – deep therapeutic expertise combined with rare disease experience. We also tap into our Rare Disease and Pediatric Center of Excellence to focus on the design and execution of clinical trials that address the unique strategic, operational, medical and scientific challenges of clinical studies in rare disease and pediatric patient populations.