You know your product(s), we know the regulatory landscape and can assist you throughout the lifecycle of your project, from protocol development, regulatory/ethics submissions through, to data management and end of study closure/publications. We want to work with you to ensure the success of your study, as we understand that patients ultimately benefit from your innovations and interventions. We support both drug and device studies.
PHARMExcel has had the opportunity to work with some of the top, global key opinion leaders over the last 10 years to deliver Phase I-IV drug and early phase medical device studies in this field. Our experience, coupled with our strong, investigator relationships, suitably places us to ensure your trial(s) are successfully delivered. Our global regulatory experts can add input, strategy, and efficiencies, based on their in-depth understanding of the local and global regulatory landscape.
We have a key focus in Alcoholic Liver Disease (ALD), Acute on Chronic Liver disease (ACLF) and non-alcoholic steatohepatitis (NASH).
Gastroenterology/Inflammatory Bowel Diseases
At PHARMExcel, our operational teams have extensive experience when it comes to conducting GI studies. We understand the everchanging regulatory landscape and the importance of delivering in a timely and expedited manner.
We have a key focus in Inflammatory Bowel Diseases (Crohn’s Disease and Ulcerative Colitis) and have conducted pivotal studies in new and emerging biosimilar technologies.
Infectious Diseases and Vaccines
Our in-house team have a thorough understanding of the complexities of running ID and vaccine trials, having worked on some rare and complex Phase I studies, in both adult and paediatric populations. We ensure maximised efficiency with study planning, regulatory submissions and enrolment.
We have a key focus on rare, infectious diseases.
In an aging population we have seen the number of ophthalmic disorders rising with significant healthcare cost implications. Research into novel treatment options therefore, remains a priority.
Here at PHARMExcel, we have developed long-lasting relationships with investigators around the world, including working with some of the world leading eye centres, providing access to some of the latest imaging technologies, including AI. This allows us to guarantee delivery of high quality, clinical trials in this area.
We have a key focus on Acute Macular Degeneration (AMD), Diabetic Retinopathy (DR) and Uveitis.
With our flexible and pragmatic approach to clinical research delivery, we have earned a reputation for taking on complex and challenging research studies in the area of Oncology/Haematology. We have the capabilities to identify key opinion leaders and high-performing sites, plan and conduct effective studies, expedite study start-up and recruitment and navigate the global regulatory landscape to expedite approvals.
We have a key focus in myeloma, lymphoma, myelodysplastic syndrome, amyloidosis, and haemophilia.
PHARMExcel has partnered with a world leading probiotics company and have been responsible for assisting with the monitoring and oversight of their UK clinical trial programme. We have, to date, undertaken numerous studies covering multiple specialty areas including hepatology, healthy volunteers/athletes, orthopaedics, spinal injuries, gastroenterology and renal.