1. Who is Ameli-biogroup?
We are a dedicated clinical trial site based in London, specializing in conducting clinical studies for sponsors. Our focus is on delivering high-quality research outcomes with efficiency and strict adherence to regulatory standards.
2. What types of clinical studies do you conduct?
We conduct clinical studies ranging from Phase II to Phase IV trials. Our experience spans various therapeutic areas including Dermatology, respiratory, cardiology, neurology, ensuring we meet diverse sponsor requirements.
3. What services do you offer to sponsors and CROs?
Our comprehensive service portfolio includes:
- Patient Recruitment & Retention: Leveraging our local network and targeted outreach to enroll diverse patient populations.
- Site Management & Training: Ensuring optimal site performance through expert staff training, site activation, and ongoing oversight.
- Data Management & Safety Monitoring: Employing rigorous procedures to maintain data integrity and patient safety.
- Regulatory Support: Facilitating compliance with MHRA, EMA, and ICH-GCP guidelines throughout the study lifecycle.
4. How do you ensure regulatory compliance and quality?
At Ameli-biogroup, quality and compliance are paramount. We strictly adhere to ICH-GCP and local MHRA standards with robust documentation practices, continuous monitoring, and regular audits to ensure full regulatory compliance.
5. What is your approach to patient recruitment in London?
Utilizing our deep roots within the London healthcare ecosystem, we implement a multi-channel recruitment strategy. This includes collaboration with local healthcare providers, targeted digital outreach, community engagement, and referral networks to optimize enrollment and retention while ensuring patient diversity.
6. Can you support global clinical trials?
While our site is based in London, we have extensive experience in supporting studies for international sponsors. Our team is adept at navigating diverse regulatory environments and coordinating cross-border research initiatives.
7. How do you manage data security and confidentiality?
We prioritize data security and confidentiality by adhering to GDPR and other relevant standards. Our established data management processes ensure secure handling, storage, and transmission of sensitive patient and study data.
8. What technological solutions do you use?
At Ameli-biogroup, we rely on proven, established methods for data collection and management to maintain accuracy and compliance. While we do not employ proprietary electronic data capture (EDC) systems, remote monitoring, or telemedicine solutions, our robust procedures and oversight ensure data integrity and operational efficiency.
9. What makes Ameli-biogroup unique?
Our strategic London location, experienced clinical research team, and commitment to personalized service set us apart. We focus on a collaborative approach where sponsor objectives guide every aspect of trial execution, ensuring high-quality results and a smooth study process.
10. How do we initiate a partnership with Ameli-biogroup?
Interested sponsors or CRO partners can contact us directly by completing our online inquiry form. We will promptly arrange a consultation to discuss your study’s specific needs and explore collaboration opportunities.