One-stop shop for your rare disease development
Conducting clinical trials in rare disease development faces several unique challenges, including:
- Lack of disease understanding
- Heterogeneity of disease
- Limited patient population
- Limited resources
- Long-term follow-up
Addressing these challenges requires collaboration and knowledge among patient groups, regulatory and other stakeholders.
At VCLS, we provide you one-stop shop with in-house resources to ensure the successful strategy and the execution of the trials for your rare disease development.
What we offer:
- Study design & protocol development. Our experts in rare diseases take the unique characteristics and complexities of the disease, patient population, and regulatory requirements into consideration to develop a robust and scientifically rigorous study design and endpoints.
- Patient recruitment and engagement. We help you to set up specialized strategies to identify and recruit eligible participants for rare disease clinical trials. We collaborate with patient advocacy groups and caregivers to ensure patient engagement throughout the trial.
- Data collection & monitoring. Our proprietary data collection systems are implemented to capture relevant information during the trial. Data monitoring processes are established to ensure data integrity, quality, and adherence to regulatory requirements.
- Statistical analysis & data management. VCLS experienced in-house statisticians and data managers work to analyze the collected data using appropriate statistical methods. We ensure data integrity, perform quality checks and generate meaningful insights from the trial results.
- Safety monitoring & adverse event reporting. We set up and implement a rigorous safety monitoring process and all are per regulatory requirements to ensure participant safety and data integrity during and after the studies.
- Regulatory strategy, submission & compliance. This includes defining the development plan, authoring ODD and informed consent from participants and maintaining privacy and confidentiality.
- Early Access Program. We provide strategic support and operational execution to expedite your clinical development in Europe through Early Access Program.