About Simbec-orion
Simbec-Orion: A Leading Clinical Research Organisation for Complex Clinical Studies
Simbec-Orion is a UK-based clinical research organisation that specializes in providing clinical trial management services across a range of areas and phases. With over 40 years of experience in the industry, Simbec-Orion has established itself as a leading provider of complex clinical studies, offering innovative solutions to meet the needs of its clients.
At Simbec-Orion, we understand that conducting clinical trials can be challenging and time-consuming. That's why we offer end-to-end solutions to help our clients navigate the complexities of the process. Our team consists of highly skilled professionals who are dedicated to delivering quality results on time and within budget.
Our Services
We provide a wide range of services to support our clients' clinical trial needs. These include:
1. Clinical Trial Management: We offer comprehensive project management services for all phases of clinical trials, from planning and design through execution and closeout.
2. Medical Writing: Our medical writing team provides high-quality documents such as protocols, investigator brochures, study reports, regulatory submissions, and more.
3. Data Management: We have extensive experience in data management for both paper-based and electronic data capture (EDC) studies.
4. Biostatistics: Our biostatistics team provides statistical analysis plans (SAPs), statistical programming support, interim analyses, final analyses, and more.
5. Pharmacovigilance: We provide pharmacovigilance services including safety reporting activities such as adverse event reporting (AE), serious adverse event reporting (SAE), expedited reporting requirements according to regulatory guidelines.
6. Quality Assurance & Compliance: We ensure compliance with Good Clinical Practice (GCP) guidelines by providing quality assurance audits throughout all stages of your study lifecycle from protocol development through final report submission ensuring adherence with ICH E6(R2) guidelines
Our Expertise
Simbec-Orion has extensive experience in conducting clinical trials across a range of therapeutic areas, including oncology, infectious diseases, respiratory diseases, and more. We have worked with a variety of clients including pharmaceutical companies, biotech firms, and academic institutions.
Our team is comprised of experts in their respective fields who are dedicated to delivering quality results. Our medical writers have advanced degrees in life sciences and are experienced in writing regulatory documents for submission to regulatory authorities such as the FDA and EMA. Our biostatisticians have advanced degrees in statistics or related fields and are experienced in designing statistical analysis plans (SAPs) that meet regulatory requirements.
Our Commitment
At Simbec-Orion, we are committed to providing our clients with the highest level of service possible. We understand that each study is unique and requires a tailored approach to ensure success. That's why we work closely with our clients throughout the entire process to ensure that their needs are met.
We also understand the importance of compliance with regulatory guidelines such as Good Clinical Practice (GCP) guidelines. That's why we adhere strictly to these guidelines throughout all stages of your study lifecycle from protocol development through final report submission ensuring adherence with ICH E6(R2) guidelines
Conclusion
In conclusion, Simbec-Orion is a leading clinical research organisation for complex clinical studies based out of UK offering end-to-end solutions for its clients' clinical trial needs across various therapeutic areas & phases while adhering strictly to GCP guidelines ensuring adherence with ICH E6(R2) guidelines . With over 40 years of experience in the industry & highly skilled professionals on board , Simbec-Orion has established itself as one-stop-shop for all your complex clinical trial management needs . Contact us today if you're looking for innovative solutions backed by expertise & commitment!