Cardiovascular Research
We deliver speedy research start-up deadlines, on-time deliveries, proactive risk management, and high-quality data as your cardiovascular CRO, all while staying within budget. We recognize that tiny biotech enterprises require a partner who can supplement their limited workforce while also being mindful of budget constraints.
We have a lot of experience dealing with smaller biotech companies and can easily adjust to your demands. Our individual cardiovascular group offers the feel of a small CRO with all of the advantages of a large CRO.
We know what it takes to execute a global, cardiovascular outcomes trial successfully (CVOT). That’s why we have CVOT-experienced personnel in medical leadership, project management, clinical operations, pharmacovigilance, and statistics who can carry out trials using established methodologies.
Endocrine and Metabolic
We have a professional team with years of experience in medical leadership, project management, and clinical operations who can carry out endocrinology studies using proven effective methodologies, no matter where they are conducted or what the indication is. This results in faster study start-up times, on-time deliverables, proactive risk management, and high-quality data delivery, all while staying under budget.
Small biotech enterprises want a partner that can supplement their small workforce while also being mindful of financial limitations. We’ve worked with a variety of smaller biopharmaceutical firms and have a lot of expertise with them. Our individual endocrinology group provides a small CRO experience with all the benefits of a large CRO, and we can easily adjust to sponsors’ demands.
Gastroenterology and Herpetology
Our gastroenterology and herpetology specialists are well-versed in a wide range of digestive disorders.
In the United States alone, gastrointestinal illnesses impact an estimated 60-70 million individuals each year. 1 Novel therapeutics in gastroenterology and hepatology are critically needed around the world. We have a specialist gastroenterology/herpetology team of 800 people who are familiar with a wide range of digestive problems.
Immunology and Inflammation
Because of the rise in immunologic and inflammatory disorders, as well as the creation of targeted medications, it is important to get novel products to market as quickly as possible while maintaining quality in a highly competitive research environment.
Our extensive worldwide and local expertise in autoimmune and inflammatory disease research is unrivaled. We have a large global network of facilities as well as experienced clinical research teams. Our therapeutic experts and validated processes, as well as our extensive training programs, are critical components in ensuring excellent data quality.
We help you find the best sites for your research.
We thrive at attracting investigative sites to work on your studies and motivate them to perform. We’ve created a global network of highly trained investigators because we’ve always recognized the value of long-term relationships with investigative locations.
Many of our CRAs and project managers have years of experience working with sites. Our therapeutic alignment, along with our cutting-edge data processing capabilities, makes investigators’ jobs easier, encouraging them to collaborate with us and give your research the attention they deserve.
Our Study Start Up and Feasibility team uses benchmark analysis, dedicated feasibility surveys, and ongoing study schedule verification to assist you in selecting the most appropriate countries and settings for commencing study.
Infectious Disease and Vaccines
The power of infectious disease and vaccine research to have a broad impact on public health is unparalleled. Every member of Syneos Health’s Infectious Disease business segment is dedicated to furthering this essential work.
True therapeutic alignment provides us with not only an unrivaled depth and breadth of expertise among our best-in-class infectious disease study teams, but also deep partnerships with well-known and trusted sites and investigators around the world – relationships that are always important, but are especially critical during fast-moving outbreaks.
COVID-19 and other emerging infectious diseases pose a threat, therefore we’re teaming up to combat it.
Vast organizational and individual experience with new illnesses, public health emergencies, and biological countermeasures, including sophisticated Zika and Ebola virus investigations, as well as other emerging health risks
Access to our Vaccine Catalyst Site Network, which includes over 30 high-performing vaccine research sites that are integrated with our processes to enable speedy trial start-up and execution, as well as high-quality subject data.
Ophthalmology Treatment
An aging global population, alongside unmet ocular illness demands that have real-world implications for quality of life, has sparked a surge of interest and opportunity in creating new eye disease treatments. Ophthalmology research is extremely specialized, requiring in-depth understanding of the patient and caregiver experience, long-term relationships with reputable research sites, and technical expertise in ocular imaging and a variety of treatment methods.
In a competitive clinical setting, there are only so many clinical research locations available. You’ll need a CRO with extensive site partnerships, a worldwide perspective on an ever-changing therapeutic and clinical research landscape, and disease-specific expertise in developing medicines, biologics, devices, and special goods for eye disease.
WE’RE THE WORLD’S LEADING PROVIDER OF NEW TREATMENTS FOR EYE DISEASE CLINICAL TRIALS.
We are the leading global provider of clinical services for both front- and back-of-the-eye illnesses, with 15 AMD trials and nine glaucoma trials completed in the last five years, as well as scores of others across a variety of conditions.
Respiratory Therapy
Chronic respiratory diseases remained the major cause of morbidity in 2017 in the world. Asthma and COPD were found to be responsible for a significant amount of the illness burden1. Between 1990 and 2017, the number of cases of interstitial lung disease and pulmonary sarcoidosis approximately doubled.
Rare lung disorders impact at least 1.2–2.5 million American patients and 1.3–3 million European patients2. Over the last decade, the medical world has become increasingly interested in conducting linked respiratory clinical studies, as well as substantial advancements in the field of uncommon diseases2.
Our professionals will provide tailored, innovative solutions to help your development initiatives while ensuring timely and high-quality delivery.
Our Respiratory Disease Expert Group is dedicated to helping people with respiratory diseases.
Our Respiratory Disease expert group and clinical operations team have extensive expertise working on worldwide respiratory studies (Europe, the Americas and Asia Pacific). Across a wide range of indications, our professionals have substantial therapeutic and regulatory experience
Women's Health
XEsearch is a big supporter of biopharmaceutical businesses working on new women’s health solutions. The following are some of our areas of expertise:
Since 2013, 86 women’s health clinical trials have been successfully designed, implemented, and executed, treating 46,800 patients at 5,240 sites around the world. Since 2013, 14 studies with a fertility focus have been successfully designed, implemented, and executed, treating 7,726 patients at 373 sites around the world.
A dedicated women’s health group within the General Medicine Business Unit (BU) with over 200 clinical, scientific, and regulatory professionals, including five full-time in-house OB-GYN physicians, executives with experience running women’s health trials, experienced project directors, project managers, and clinical research associates (CRAs)
We routinely engage across our integrated network of clinical and commercial subject matter experts within XEsearch Research to ensure we have considered your trial needs from every feasible viewpoint, given the numerous disciplines that overlap with women’s health research. For example, while performing a closely defined vaccine study with pregnant women recently, we drew on our infectious disease colleagues’ significant vaccine knowledge to assure the best protocol development for this highly targeted patient population. You can get the most complete planning, management, and oversight for your clinical trials at every level because to XEsearch Research unique ability to tap upon knowledge from across the clinical and commercial continuum.
For a clinical study, there is no such thing as a “one-size-fits-all” outsourcing strategy. This is particularly true in the field of women’s health. Our therapeutically aligned experts listen to your needs and collaborate with you to customize the design, from protocol considerations through risk-based monitoring plan definition. We’ll be fluid and adaptable in order to complete your study as quickly as possible while keeping data integrity.
CNS Analgesia
Xesearch is well-known for its pain management work, which includes the design, feasibility, execution, analysis, and interpretation of studies in a variety of acute, subacute, and chronic pain problems, as well as unusual indications and pediatric pain.
WE GET RESULTS FOR YOU.
Because of our 100 percent therapeutic alignment and Customer Relations Executive (CRE) model, everyone on your study team, from project leads to clinical research associates (CRAs), is well-versed in the complexities of analgesia studies and their successful execution, resulting in optimal project delivery and site impact.
We have co-designed and conducted multiple Phase 3 acute and chronic pain studies leading to NDAs, including three recent agency approvals; we have completed numerous positive proof-of-concept studies (POCs) leading to pivotal programs in analgesia indications; and we have completed numerous positive proof-of-concept studies (POCs) leading to pivotal programs in analgesia indications.
We’ve managed studies with prohibited substances all throughout the world.
Our in-house Clinical Tracking and Training (CST) team uses strong rater training and eligibility surveillance procedures to assist limit the placebo effect in analgesic research and assure high-quality data.
Instrument selection, validation, and translation, global diary set-up, training, and data flow management are all streamlined thanks to our extensive experience with different electronic clinical outcome assessment (eCOA) providers and systems.
In worldwide research, we’ve also set up and overseen nerve conduction velocity (NCV) testing and quantitative sensory testing (QST) assessments.
Our connections with key opinion leaders (KOLs) in analgesia and clinical research locations are unrivaled.
Due to our therapeutic alignment, we are able to connect with important opinion leaders, investigators, and sites with focus and peer-to-peer scientific competence in order to build strong partnerships.
We have substantial chronic pain site networks in most globe geographies for access to chronic pain patient populations, and our Catalyst Pain Network provides you with more than 20 proven US sites for the conduct of diverse post-surgical pain models.
Clinical Surveillance Team (CST)
Your trial stays on track thanks to our clinical surveillance monitoring.
With our unique in-house Clinical Surveillance and Training (CST) capabilities – the only one of its kind at a CRO – we ensure data integrity.
According to research, not all people randomized into mental health clinical trials fulfill the rigor of selection anticipated by the sponsor. High rates of protocol drift, whether caused by a misunderstanding of complex protocol criteria or a failure to follow more basic standards, result in a research population that offers unusable, non-actionable data.
Our Clinical Surveillance and Training service is an all-in-one solution for ensuring that the proper study subjects are enrolled in your studies. To assure on-protocol subject selection, this global team of doctoral-level doctors and dedicated project managers undertake thorough, collegial, and culturally sensitive eligibility checks. Even while funding are being slashed, the ever-increasing intricacy of CNS research necessitates increased attention at the site level. Answers that are based on unambiguous and reliable facts are critical for business success.
CNS Neurology
We know what goes into running a successful neurology clinical study. We have managed all of these complexities and more across a range of challenging neurological study designs and difficult-to-recruit indications in neurology with a consistent record of delivering positive trial results. From recruiting the right patients to ensuring their assessments are completed properly by trained experts to ensuring all stakeholders involved are aligned, we have managed all of these complexities and more across a range of challenging neurological study designs and difficult-to-recruit indications in neurology with a consistent record of delivering positive trial
Because of our 100 percent therapeutic alignment and Customer Relations Executive (CRE) model, everyone on your study team, from executive leadership to clinical research associates (CRAs), is well-versed in the complexities of neurology studies and how to execute them successfully, resulting in optimal project delivery and site impact.
We provide unrivaled specialty knowledge and top-tier personnel.
Each neurology study team includes of board-certified neurologist medical directors, clinical psychologists with doctorate and master’s degrees, and scientists with extensive experience in a variety of neurological illnesses, including:
Pathophysiologies of neurodevelopment and neurodegeneration in all indications
SMA, Duchenne Muscular Dystrophy, Lennox-Gastaut syndrome (LGS), Dravet syndrome and cervical dystonia (CD), myasthenia gravis (MG), and Tourette’s syndrome are examples of rare and orphan diseases.
We are the industry leader in Parkinson’s disease and seizure disorders.
There is no therapy modality that is too complicated.
We have cutting-edge expertise in both disease-modifying (gene, oligonucleotide, immunological, and cell therapies) and symptomatic treatments.
Favorable pivotal studies resulted to NDA/BLA/MAA approvals in PD, SMA, epilepsy, Duchenne Muscular Dystrophy, and narcolepsy, and positive Proof-of-Concept Studies (POCs) have supported program progression in PD, SMA, epilepsy, MG, and DMD.
CNS Psychiatry
For Your Psychiatry Studies, We Offer Deep CNS Expertise, Industry Relationships, and Reliability in Delivery
We can assist you in addressing the substantial problems associated in psychiatry clinical research, from study design to site selection, subject recruiting and eligibility assessment, quality and evaluation of raters, and finally monitoring and delivery of high quality data.
Everyone we assign to your study team, from senior leadership to clinical research associates (CRAs), is entrenched in the subtleties of psychiatry studies and their effective execution, resulting in optimal project delivery and impact on sites. Our operational staff and scientific experts are situated in the same business unit and work together to ensure clinical program quality.
Your operational team is made up of project directors, project managers, clinical operations leads, and clinical research associates who are all experts in CNS illnesses and ready to get started on your studies.
Your XEsearch Health Psychiatry scientific team includes clinical psychologists, psychiatrists, STEM scientists, and pharmacologists with advanced degrees and clinical experience in affective, psychotic, anxiety, and developmental disorders.
Targeted Therapies
Predictive Medicine: Addressing the Challenges
Multiple medications and personalized treatments are currently being tested against heterogeneous cancers that were previously thought to be one illness. Our Targeted Therapeutics Team focuses solely on these emerging treatments, such as biomarker-driven therapies, biosimilars, antibody drug conjugates, and other small molecules.
These new therapy approaches necessitate a thorough therapeutic understanding as well as extensive expertise with various therapeutic goals.
Our clinical experts are presently supporting novel approaches to precision medicine in solid tumors, working with cutting-edge medicines such as combination immunotherapies and sophisticated research designs at every stage.
Novel and Emerging Therapies
We take a forward-thinking approach to oncology medication development, including unique trial designs such as cellular and gene therapy clinical trials, as well as investigator-led and cooperative group trials.
Our Novel and Emerging Therapies group is further focused in three areas to provide an unrivaled depth of expertise:
Our specialized Hematology-Oncology Teams have worked on some of the most promising novel and emerging therapies in development, transitioning them from early phase to marketing authorization in indications ranging from non-lymphoma Hodgkin’s and chronic lymphocytic leukemia to acute myeloid leukemia and multiple myeloma.
For instance, in the field of hematology and oncology…
The Leukemia and Lymphoma Society’s “BeatAML” Master Trial, a ground-breaking targeted therapy umbrella trial aimed to hasten the development of novel medicines for acute myeloid leukemia patients, has chosen us to provide full-service clinical development support.
In the field of cell and gene therapy…
We recognize that these clinical trials frequently entail treatment components that are unfamiliar to investigators, site staff, and patients, as well as very complicated logistical issues and take place in a quickly changing regulatory environment.
The patient journey through these trials is also unique in that it entails a one-time therapy and long-term follow-up over several years, a length of time that frequently corresponds with changes in patients’ lifestyles, which can make patient retention difficult.
Immuno-Oncology
Our Immuno-Oncology Project Team is solely dedicated to research into medicines that stimulate the immune system to fight cancer. Our clinical experts are presently supporting novel approaches to precision medicine in solid tumors, working with cutting-edge medicines such as combination immunotherapies and sophisticated research designs at every stage.
We were, in fact, among the first to conduct clinical trials in immunotherapy.
We oversaw the investigations that led to the approval of the first checkpoint inhibitor, from Phase 1 to marketing approval and commercialization.
We’re now undertaking clinical trials on the cutting edge of immunotherapy advances…
In the last five years, there have been two immuno-oncology studies involving over 23,000 patients around the world.
…as well as research into novel immunomodulators and therapy combinations.
Immunotherapy Approaches that are More Effective
Immuno-oncology therapy paradigms, in combination with other targeted medicines and niche patient populations, all necessitate close supervision to ensure proper safety management and the release of reliable efficacy data.