About Continuum india llp
Continuum India LLP: Your Trusted Partner in Drug Safety
Continuum India LLP is a leading drug safety company that offers comprehensive and specialized services to pharmaceutical companies, biotech firms, and healthcare organizations. With a team of highly skilled professionals and state-of-the-art technology, we provide end-to-end solutions for all your drug safety needs.
Our mission is to ensure patient safety by providing timely and accurate information on adverse drug reactions (ADRs) and other safety concerns related to drugs. We are committed to delivering high-quality services that meet the regulatory requirements of different countries.
At Continuum India LLP, we understand the importance of pharmacovigilance in the drug development process. Our team of experts has extensive experience in handling complex pharmacovigilance tasks such as signal detection, risk management, benefit-risk assessment, and post-marketing surveillance.
We offer a wide range of services that include:
1. Case Processing: We provide end-to-end case processing services for adverse event reporting. Our team ensures timely collection, processing, evaluation, and submission of individual case safety reports (ICSRs) as per regulatory guidelines.
2. Medical Review: Our medical review team comprises qualified physicians who conduct medical review activities such as causality assessment, seriousness determination, labeling assessment etc., ensuring compliance with global regulations.
3. Aggregate Reporting: We prepare periodic aggregate reports such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Annual Safety Reports (ASRs), etc., using advanced tools like ARISgโข software.
4. Signal Detection & Management: Our signal detection experts use sophisticated statistical methods to identify potential signals from various data sources like spontaneous reports or electronic health records (EHRs). They also perform signal validation activities using various techniques like data mining algorithms or expert judgment methods.
5. Risk Management & Benefit-Risk Assessment: We develop risk management plans (RMPs) based on the safety profile of the drug and perform benefit-risk assessments to ensure that the benefits of a drug outweigh its risks.
6. Post-Marketing Surveillance: We conduct post-marketing surveillance activities such as literature review, social media monitoring, and other data sources to identify any new safety concerns related to drugs.
Our team is well-versed in global regulations such as FDA, EMA, MHRA, TGA, etc., and we ensure compliance with all applicable guidelines. We use advanced technology like ARISgโข software for case processing and aggregate reporting activities.
At Continuum India LLP, we believe in building long-term relationships with our clients by providing high-quality services at competitive prices. Our team is committed to delivering timely and accurate information on drug safety issues so that you can make informed decisions about your products.
Contact us today at +91-172-671-1200 to know more about our services or schedule a consultation with one of our experts. Let us be your trusted partner in drug safety!