Therapeutic Expertise
Oncology
Since 2016, numerous of innovative drugs from the top R&D directions, mostly represented by selective cancer targeting drugs and immuno-oncology drugs, have successful entered the clinical trials and further been approved for clinical practice as a treatment of solid tumors, lung cancer, breast cancer, lymphoma, liver cancer and leukemia etc. Since its establishment, Proswell Medical Development Center has focused on bringing together international standard, local regulations and knowledge about real clinical practice needs to conduct clinical trials for new drugs in the field of oncology in cooperation with oncology national level key opinion leaders and local and overseas Sponsors. Such joint effort resulted in market authorization granted for numerous innovative drugs, therefore delivered cutting-edge treatment methods to the patients in need. Even during the outbreak period of COVID-19, Proswell achievements and contribution into public healthcare sector was demonstrated by the augmentation of the number of new oncology drug clinical trials. Proswell Medical Development Center has established and continue to maintain long-term and stable cooperative relationship with best in a country cancer treatment hospitals. Hundreds of clinical trials of each phase have been completed through the years, and 13 innovative drugs have successfully been marketed in China. Our rich clinical trial experience is a useful tool for our sponsors to explore new opportunity for applications of new investigational drugs and to design clinical trial strategy with accuracy, which includes precise benchmarking of oncology treatment protocols and subject screening methods to develop a complete procedures and concepts of risk management and risk control and project management preventive measures for oncology clinical trials. That resulted in reduction of all kinds of risks and improved efficiency. Our dedicated oncology team are rigorous thinkers with creative eye on doing professional things, where the clinical experience meets fundamental pharmaceutical and medical knowledge to consolidate and dedicate all our efforts to successfully complete oncology clinical trials. Our oncology experience includes but are not limited to solid tumors, breast cancer, lymphoma, liver cancer, leukemia, gastric cancer, glioma, myeloma, etc. We are experienced in conducting trials for different types of innovative drugs, biosimilar and generic drugs. The drug mechanisms of action are mostly realized through cytotoxicity caused by selective cancer targeting drugs and immuno-oncology drugs, for instance, programmed death protein 1 (PD-1), epidermal growth factor receptor (EGFR), programmed death ligand 1 (PD-L1), human epidermal growth factor receptor 2 (HR-2), etc.
Oncology
Ophthalmology
The number of cases of cataract, myopia, fundus disease and other age-related eye diseases has been rapidly increased through the years. The concept of precision medicine has promoted the quick development of new ophthalmic drugs and therefore emerging need in conducting clinical trials for these innovations was observed to arise. Stem cell transplantation is considered to have a good therapeutic value for the treatment of retinal diseases. The United States and Japan regulatory agencies have approved several clinical trials in the field of retinal bioengineering to treat AMD and retinitis pigmentosa. From the other hand, Lucentis, Arbacicept and Conbercept became classic cases of VEGF targeted inhibitors successful application in ophthalmology. Stem cell replacement therapy as a modern trend in regenerative medicine is a prominent approach for future treatment of different diseases in Ophthalmology, for instance, corneal diseases and retinal diseases. From the other hand, Gene Therapy as a new direction has a greatest potential to cure genetic diseases with already identified pathogenic genes. Proswell Medical Development Center Ophthalmology Team presented by senior and professional clinicians from ophthalmology field and senior level pharmacologists from R&D field. They are familiar with clinical diagnostic procedures and protocols of standard treatment for glaucoma, cataract, fundus disease etc. We have conducted over 20 ophthalmology clinical trials for such indications like dry eye, wet age-related macular degeneration, crystalline retinal degeneration, glaucoma, post cataract anti-inflammatory, allergic conjunctivitis, Bietti's crystalline dystrophy (recombinant adenovirus gene carrier for the treatment of rare disease in ophthalmology),[Explanation why the good sentence was changed: Because earlier we mentioned “indications like”, further we should put in a sentence terms classified as indications in the medical vocabulary, which, for instance, is a Bietti’s crystalline dystrophy. Further, the other part as explanation could be placed in “()”. ][OK ] uveitis, acquired blepharoptosis, etc., and covering all clinical trial phases, IIT and post marketing studies. The therapeutics administration methods include traditional eye drops and intravitreal injection, as well as subretinal injection required for lacrimal canalicular implantation and gene therapy. In terms of the long-term cooperation development approach, we have established a good cooperative relationship with many well-known local and overseas ophthalmology pharmaceutical companies and reputed industry experts. Our ophthalmology dedicated medical team provides one stop medical service for all indications and all trial phases for the new investigational drugs, including but not limited to: CDP development, medical writing, Health Authority communication, protocol development, medical monitoring, and CSR development.
Ophthalmology
CVS & CVD
The prevalence rate of cardiovascular system and cerebrovascular diseases is drastically increasing in China with age decrease of affected population. The mortality rate of cardiovascular and cerebrovascular events remains the first one among of all causes of death. At present, there are still many unmet clinical needs in the cardiovascular and cerebrovascular field, especially, the high rate of disability after strokes, the risk of heart failure after myocardial infarction thrombolysis and interventional therapy. This situation around unmet needs make the research and development of related chemicals and natural compounds very attractive for cardiovascular scientific community with further transfer into clinical stage, that in turn gives rise to a need in qualified clinical trial service providers. At the same time, the single cell sequencing technology application in the studies of cardiovascular diseases pathogenesis and progression and the development of cardiomyocytes regenerative therapies emphasizes the pivotal role of cardiac inflammation in disease pathogenesis and progression. Gene therapy became research hot spot. PAGln represents a new intestinal microbiota dependent metabolite that promotes CVD, making it to be a potential target for personalized therapy in the future. Pluripotent stem cell technology also entered clinical trial stage as potential treatment after cardiac damage. The innovation of drug development makes cardiac xenotransplantation possible. Proswell Medical Development Center Cardiovascular and Cerebrovascular team keeps up with the times and is aware of research hot spots and trends in clinical trials both at home and abroad. The team is led by senior first line clinical experts who have been engaged in clinical work and research for more than 20 years. They have rich professional experience in the diagnostic and treatment of cardiovascular and cerebrovascular diseases such as coronary heart disease, hypertension, heart failure, arrhythmia, stroke, and other diseases. The diverse and excellent cooperation relationship with industry experts and hospitals gives an opportunity to our sponsor to solve serious problems faced during the study and facilitates the conducting of clinical trials of all phases. Our cardiovascular and cerebrovascular dedicated medical team provides one stop medical service for all indications and all trial phases for the new investigational drug, including but not limited to: CDP development, medical writing, Health Authority communication, protocol development, medical monitoring, and CSR development.
CVS & CVD
Respiratory
As the most basic physiological process, breathing and the whole respiratory tract involved in this act are closely related to human health. In recent years, studies on airway microecology imbalance during COPD and bronchiectasis have revealed, that the characteristics of lower airway microecology are closely related to progression of respiratory diseases and provided new insights on medical treatment options, and therefore caused rising of new ideas about clinical intervention into microecology imbalance to stop disease progression. Regarding asthma, the research and development of new drugs for the upstream inflammatory pathway became a leading direction in the treatment for asthma patients, including patients with non-type 2 increased airway inflammation. Bronchial thermoplasty, bronchoscopy, lung volume reduction, targeted denervation and other technologies have made great progress in the treatment of COPD and asthma. However, in the field of acute hypoxic respiratory failure treatment, the existing clinical trials results revealed, that clear therapeutic targets leading to reduction of the mortality of patients have not been discovered yet, and it requires to put more efforts to explore the effectiveness of other treatment approaches. Proswell Medical Development Center Respiratory Disease team always happy to assist clients with research and development of new respiratory drugs. Respiratory Disease team leader has many years of respiratory clinical work experience in diagnostic and treatment of respiratory diseases like refractory asthma, chronic obstructive pulmonary disease, pulmonary infectious disease, pulmonary vascular disease, interstitial pulmonary disease, and ability to organically combine the clinical diagnosis and treatment experience and skills with the design and implementation of clinical trials. Our team has participated in different projects including pulmonary embolism, new coronavirus pneumonia treatment, chronic obstructive pulmonary disease, and other respiratory diseases. In terms of therapeutics diverse administration methods experience, our team successfully conducted trials for drugs administered orally, by inhalation, by injection and as a spray. We have built good cooperation and relationship with many well-known respiratory system drugs developing companies and reputed industry experts in China and around the globe. Our respiratory dedicated medical team provides one stop medical service for all indications and all trial phases for the new investigational drug, including but not limited to: CDP development, medical writing, Health Authority communication, protocol development, medical monitoring, and CSR development.
Respiratory
Other TA
We have successfully completed over 1000 clinical trials and post marketing studies in more than 20 therapeutic areas, which include CNS and Neuropsychiatry, Immunology, Infectious Diseases, Vaccine Trials, Dermatology, Endocrinology, Hematology, Hepatology, Pain Management, Gastroenterology, Pediatrick, Otorhinolaringology, Critical Care, Rheumatology, Ortopaedics, Rare Indications and Medical Devices.
Other TA