Case studies
At Smooth Drug Development, we understand the pivotal role of clinical trials in the creation and approval of new medications and treatment strategies. They form the backbone of modern medicine, providing key data for new therapies and contributing significantly to our understanding of human health.
Smooth Drug Development has expertise in many therapeutic areas, including oncology and hematology, cardiology, gynecology, infectious diseases, neurology/CNS, vaccines, and rare diseases.
For each trial and indication, we work with passion and dedication, leveraging our operational, regulatory and medical experts to develop the best strategy for your trial to bring new, often life-changing therapies to patients.
Our comprehensive portfolio includes studies of innovative drugs, generics and biosimilars.
We contributed to different phases of the drug lifecycle, from early-stage exploration to post-marketing evaluations. We have repeatedly conducted studies, the results of which led to the registration of drugs.
Explore our research programs for more details about our extensive contributions to medical science and the future of healthcare.
Oncology and Oncohematology
Oncology trials are becoming increasingly complex. A focus on unique patient subpopulations, intensive clinical trial procedures, inclusion of PK sampling, novel complex treatments, intense competition for patients, high site workload, need for advanced equipment are all becoming standard in oncology research.
The cornerstone of Smooth Drug Development's success in conducting complex oncology trials is site setup and management. Our trial team provides a full range of site recruitment, logistics and document management support. Our team is always available to help reduce complexity and logistical hurdles, and to assist investigators in ensuring patient safety and quality at the sites. We also provide sites with all the necessary electronic solutions, such as eISF, to manage data quickly and with good quality, allowing them to digitize and automate investigator site files, protocols and team documents.
Our expertise and true partnership means our sponsors can trust us to manage their oncology trials, regardless of size or complexity.
Our experience includes trials in solid and liquid tumors: breast cancer, colorectal cancer, lung cancer, myelodysplastic syndrome and chronic myeloid leukemia (CML).
In addition to Phase III clinical trials, we also have a significant focus on early phase trials, including first-in-human clinical trials.
Cardiology
We have extensive experience in cardiovascular trials across the entire drug spectrum, including hypertension and thrombosis, to name a few. Our adjudication services help ensure the highest quality data, and because we're already involved in cardiovascular projects across our network of sites, we're able to accelerate timelines with our experience and agreed-upon contract templates, as well as closely monitor sites to ensure high performance.
Women health
Smooth Drug Development has strong relationships with investigators that allow us to quickly identify the best sites for clinical trials in women's health. Over the past 15 years, Smooth Drug Development has provided quality CRO services to numerous pharmaceutical and biotechnology companies developing women's health products.
Our experience includes clinical trials in contraception, pain, gynecological infections, pregnancy and reproduction.
We are proud that our team contributed to the registration of a vaginal ring for contraception and a drug for candidiasis vulvovaginitis.
Infectious disease
Our team has extensive experience in viral indications including COVID-19, Influenza, Hepatitis B, C and D.
We are proud to have been responsible for managing the entire development program for the only approved drug in HDV. We were responsible for Phase I, Phase II and Phase IIb in HDV.
Rare diseases
Smooth Drug Development has experience in rare diseases.
Drug development in rare diseases often involves fragile and pediatric patients, each of which adds to the complexity and challenges of trials.
Working with fragile populations and children requires specialized expertise. Our family-centric approach means that we focus on making a positive impact on the lives of rare disease patients and their families by providing logistics, accommodation, meals and travel for such patients, as well as home visits by doctors and nurses. We are experienced in organizing the complete management of logistics for patients and their families to clinical research sites. In rare disease trials we fully understand the challenges associated with the rarity of patients, in such trials every patient counts and we are ready to meet all types of challenges in organizing patient visits to sites or patient home visits.
In rare disease trials, we provide drug development strategy, evaluation of epidemiology and countries suitable for the trial, statistical input into the study protocol taking into account the rarity of the patients, concierge patient support, interaction with regulatory authorities and communication with patient organizations.
We have experience in Gaucher disease, Phenylketonuria, X-ALD, Cystic Fibrosis, Pituitary Dwarfism, Primary Immunodeficiency, Primary Immunodeficiency in children, Paroxysmal Nocturnal Hemoglobinuria.
Vaccines
Our extensive vaccine experience and capabilities can help your trials succeed throughout the life of your program.
We've done extensive work in the prevention of COVID-19, MERS, influenza, pneumococcal, and polio infections, including development experience in pediatric and geriatric vaccines.
We've developed methods for recruiting study participants from neonates to geriatrics, with our network of research sites including vaccine centers, outpatient clinics, and hospitals. This ensures you have access to the subjects you need.
We are proud to have been involved in a COVID-19 trial that led to drug approval.
Neurology
Smooth Drug Development has a long history of conducting clinical trials in the neurosciences, including neurology, pain and psychiatry.
Our teams and experts have strong relationships with key opinion leaders, sites and patient groups that are critical to successful clinical trials.
In psychiatry, we have conducted studies in depressive disorders, anxiety disorders, alcohol dependence, PTSD and schizophrenia.
In pain, our team has been involved in trials for migraine, chronic musculoskeletal pain, post-operative pain, oncologic pain and acute post-operative pain, dental pain, trauma pain, dysmenorrhea pain, osteoporosis pain, etc. For pain studies, we extensively use ePRO solutions. ePROs have proven to be an effective method of capturing patient symptoms that can lead to a more thorough and consistent assessment of patients' physical and emotional health status and quality of life.
Our team also has hands-on experience in multiple sclerosis. Being involved in several large observational studies in MS, Smooth Drug Development included more than 4000 patients.
Our company is proud to be involved in several studies leading to the marketing of drugs for schizophrenia and pain.
More therapeutic areas
Our customers break new ground every day in pursuit of treatments and cures, opening doors to patients who have exhausted every option. We’re committed to helping these innovators navigate the obstacles of novel drug development with a wide range of therapeutic expertise and insights. Our experience also includes the following areas:
- Allergology
- Dermatology
- Endocrinology
- Gastroenterology
- General Medicine
- Hematology
- Hepatology
- Immunology
- Nephrology
- Ophthalmology
- Otolaryngology
- Proctology
- Pulmonology
- Respiratory diseases
- Rheumatology
- Surgery
- Trauma