Vaccine clinical trials
Vaccine development has always been a difficult process, but during a pandemic, the time available to drug manufacturers to create new drug products is drastically short.
Today, the world is in a race to create new vaccines against the new coronavirus infection, SARS-CoV-2, and the resulting disease, COVID-19. Pharma and CRO players, determined to defeat this infection, which continues to affect millions of people, have been forced to change their approaches to vaccine clinical trials.
To meet this challenge in a timeframe that would normally be considered impossible, Smooth Drug Development uses innovative methods to conduct vaccine clinical trials.
Smooth Drug Development provides clinical research services for vaccines, including SARS-CoV-2 vaccines. Our experience includes conducting influenza vaccines, COVID-19 vaccines, and pneumococcal vaccines. We have experience working with diverse populations: children, the elderly, pregnant women, etc.
Smooth Drug Development makes extensive use of innovative tools when conducting clinical research with vaccines:
- Study Document Development. Our scientific department has extensive experience in writing protocols and preparing other study documents. All vaccine clinical trial designs are developed according to regulatory requirements and World Health Organization recommendations. Smooth Drug Development's experience in vaccine clinical trials helps to handle complexities such as dealing with placebo design.
- Regulatory experience. The Smooth Drag Development team also has experience in adapting clinical trial documents for local legislation in the EAEU (The Eurasian Economic Union) region to meet regulatory requirements. In case of requests from the regulators, the study team is ready to collect all necessary information to respond to the request as soon as possible and advise the client on all issues arising during the preparation of a set of documents for submission, relying on knowledge of the changing regulatory framework at local, regional and global levels.
- Collaboration with clinical research centers. Thanks to many years of experience in conducting clinical trials in EAEU countries, Smooth Drug Development has contacts with a large number of medical organizations with experience in vaccine clinical trials. We cooperate with professional clinical trial centers that have access to a large population of subjects of different ages and provide rapid recruitment. This is especially relevant for vaccine studies because such studies often include thousands of subjects.
- Ability to process large data sets. A self-developed Data Management system (Smooth EDC) allows automatic validation of new and entered data spending a minimum of time on traditional manual data processing cycles. In addition, risk-based data monitoring optimizes source data verification (SDV) time.
- Electronic source documentation. Smooth EDC has electronic source documentation functionality, which helps to avoid the time-consuming transfer of data from patient records to the EDC, and enters data directly into the EDC. The system has functionality to randomize, assign and account investigational products at the clinical research sites, which helps track drug shipments and drug accountability online.
- eTMF/eISF (electronic Trial Master File and Investigator Site File). The Smooth eTMF/eISF module gives you the ability to maintain the study and site file electronically and check study documents online.
- Electronic Patient Diary. Smooth ePRO allows data to be collected from patients remotely, replacing center visits and reducing the burden on center staff and increasing adherence to the Protocol in clinical trials subjects. Our ePRO solutions reduce data monitoring time. In addition, these systems allow for remote data monitoring, reducing the number of monitoring visits to the site and the length of time CRAs are at the clinical research centers.
- Patient visits at home or remote visits. Our company has experience in conducting home visits of subjects (home visits by a nurse or doctor) or organizing taxi for subjects to conduct visits at the center.
The pandemic has had a significant impact on the vaccine clinical trials market, proving that the development time of vaccines and other drugs can be shortened by introducing new technologies and using previous experience. Our company believes that these tools can be used in vaccine development without loss of quality and without compromising the safety of clinical trials subjects.