Home About Us Services Drug Safety News & Events Contact Us Pharmacovigilance Compliance Safety department and vendor audits and inspection preparedness Needs assessment and gap analysis Regulatory inspection corrective actions SOP development and training Staff drug safety training and other corrective and preventative actions © 2021 Tab Clinical Contact Us Phone: 919-694-5454 Email: info@tabclinical.com Address 2000 Regency Parkway Suite 255 Cary, NC 27518 United States

Home About Us Services Drug Safety News & Events Contact Us Drug Safety TAB Clinical provides a broad range of pharmacovigilance services to the biopharmaceutical industry. TAB Clinical has an experienced team of pharmacovigilance practitioners that helps companies manage the safety of their products with a regulatory-compliant, best-practices approach. Our pharmacovigilance team is dedicated to ensuring patient safety and supporting your companies’ efforts to maximize your product’s benefit-risk profile. TAB Clinical’s experienced operational and medical teams can integrate seamlessly with your team to provide a full suite of pharmacovigilance services. Services We provide targeted, a la carte safety offerings or serve as your fully functional safety department. Our full-service solutions (clinical and post-marketing) include: Clinical Safety Surveillance Postmarketing Pharmacovigilance Data Management Solutions Risk Management Pharmacovigilance Compliance Document Writing and Data Analyses © 2021 Tab Clinical Contact Us Phone: 919-694-5454 Email: info@tabclinical.com Address 2000 Regency Parkway Suite 255 Cary, NC 27518 United States

Home About Us Services Drug Safety News & Events Contact Us Risk Management US Risk Mitigation and Evaluation Strategies (REMS) and REMS assessments EU Risk Management Plans (RMP) including safety specification and pharmacovigilance plans Developmental RMP (DRMP) © 2021 Tab Clinical Contact Us Phone: 919-694-5454 Email: info@tabclinical.com Address 2000 Regency Parkway Suite 255 Cary, NC 27518 United States

Home About Us Services Drug Safety News & Events Contact Us News & Events TAB Clinical Overview Posted: February 2, 2015 TAB Clinical CNS Experience Posted: February 2, 2015 TAB Clinical’s Complete GI Platform Posted: February 2, 2015 © 2021 Tab Clinical Contact Us Phone: 919-694-5454 Email: info@tabclinical.com Address 2000 Regency Parkway Suite 255 Cary, NC 27518 United States

Home About Us Services Drug Safety News & Events Contact Us Safety Data Analysis and Document Writing IND applications/ IMPD Clinical study reports Periodic Benefit-Risk Evaluation Report (PBRER) Periodic adverse drug experience report (PADER) IND annual and EU Annual Safety Reports Developmental safety update report (DSUR) Document preparation for data Monitoring committees (DMC) and event review/ adjudication committees Patient narrative writing NDA, BLA and MAA document writing Cumulative safety data analyses: integrated summary of safety (ISS), summary of clinical safety, and postmarketing datasets © 2021 Tab Clinical Contact Us Phone: 919-694-5454 Email: info@tabclinical.com Address 2000 Regency Parkway Suite 255 Cary, NC 27518 United States