About Pivotal
Pivotal: A Leading Contract Research Organisation
Pivotal is a Contract Research Organisation (CRO) that provides high-quality clinical research services to pharmaceutical, biotechnology, and medical device companies. With a team of experienced professionals and state-of-the-art facilities, Pivotal offers end-to-end solutions for all phases of clinical trials.
At Pivotal, we understand the importance of scientific insight in clinical research. That's why we have a team of experts who are well-versed in various therapeutic areas and have extensive experience in designing and conducting clinical trials. Our scientific expertise enables us to provide our clients with valuable insights into their products' safety and efficacy.
We also believe that technology plays a crucial role in modern-day clinical research. That's why we use cutting-edge technologies to streamline our processes and ensure data accuracy. Our advanced technologies enable us to collect, manage, analyze, and report data efficiently.
Moreover, at Pivotal, we have access to vast resources that allow us to conduct complex studies with ease. We have state-of-the-art facilities equipped with the latest equipment for sample processing and analysis. We also have an extensive network of investigators who can recruit patients quickly for studies.
Our Services
Pivotal offers a wide range of services that cover all aspects of clinical research:
1) Clinical Trial Management: We provide end-to-end solutions for managing clinical trials from study design to final reporting.
2) Data Management: Our data management services include database design & build-up; data entry; query management; coding; validation & quality control checks; statistical analysis plan development & execution; interim/final database lock & transfer activities.
3) Biostatistics: Our biostatistics team provides statistical support throughout the entire study lifecycle from protocol development through regulatory submission including sample size calculation/justification; randomization schedule generation/validation/implementation/maintenance/tracking/reporting activities as well as statistical analysis plan development & execution.
4) Medical Writing: Our medical writing team provides high-quality documents for regulatory submissions, including clinical study reports, protocols, investigator brochures, and other documents.
5) Regulatory Affairs: We provide regulatory support throughout the entire study lifecycle from protocol development through regulatory submission including preparation of IND/CTA/NDA/BLA submissions; interaction with regulatory authorities; and maintenance of product licenses.
Our Approach
At Pivotal, we believe in a collaborative approach to clinical research. We work closely with our clients to understand their needs and develop customized solutions that meet their specific requirements. Our team is committed to providing high-quality services that exceed our clients' expectations.
We also believe in transparency and open communication. We keep our clients informed about the progress of their studies at every stage and provide regular updates on timelines, budgets, and deliverables. Our goal is to build long-term relationships with our clients based on trust and mutual respect.
Conclusion
In conclusion, Pivotal is a leading Contract Research Organisation that provides high-quality clinical research services to pharmaceutical, biotechnology, and medical device companies. With a team of experienced professionals and state-of-the-art facilities, Pivotal offers end-to-end solutions for all phases of clinical trials. Our scientific expertise, advanced technologies & vast resources enable us to conduct complex studies efficiently while maintaining data accuracy & quality standards. Contact us today for more information about how we can help you achieve your clinical research goals!