TranScrip Drug Safety, Pharmacovigilance and Risk Management

TranScrip can identify, implement and lead full drug safety, pharmacovigilance and risk management programmes for regulatory approvals, label extensions and safety monitoring requirements, through a team comprising expert senior physicians and safety scientists.

Expertise
Experience

TranScrip Drug Safety, Pharmacovigilance and Risk Management Experts

TranScrip’s Drug Safety and PV team has worked on a wide range of projects; from those in early clinical development through to post licensing pharmacovigilance. Some examples for both large and small companies include ongoing signal management activities and the development of safety documentation such as periodic reports and Risk Management Plans. In addition TranScrip offers EU Qualified Person for Pharmacovigilance (QPPV) services and relevant training programmes.

Sarah Daniels
Head of Drug Safety and Pharmacovigilance

Sarah has been with TranScrip since 2009 and leads the TranScrip Drug Safety team. During this time, she has overseen a number of successful projects ranging from signal detection and SmPC label harmonisation to drug safety narratives review. In addition she has assumed the role of clinical safety lead for several successful oncology indication expansion programs involving many interactions with regulatory agencies. Sarah has over 20 years’ experience in the pharma industry before joining TranScrip. More recent previous roles include EU QPPV and Head of Drug Safety (UK Affiliate) for Roche Products Ltd. She also held various senior positions within SmithKline Beecham and ConvaTec.

Case Study

TranScrip has led drug safety programmes to successful regulatory outcome as described in the case study below:

Challenge
A company with a major marketed oncology product loses the Lead Clinical Safety physician, threatening the ongoing further development of the product and defence of the label at EMA and FDA.
Solution
TranScrip Partners provided at short notice a highly experienced oncology drug safety physician, who assumed global safety leadership.
Result
The development programme was able to continue and the label extensions were successfully negotiated with the regulatory agencies.
Company Product Phase Indication and Service Therapeutic Area
Top 50 Anti-inflammatory Translational Safety physician support on early phase studies. CNS
SME Antibiotic Translational Support PV from Phase I programme and explore safety signal from three phase I studies. Infectious Diseases
SME Antibiotic Translational Annual safety reports and review of safety and DDI sections of FDA and EMA briefing materials. Infectious Diseases
Top 50 Anti-inflammatory Translational Preparation of Phase I DSURs for two different biological anti-inflammatories. Internal Medicine
Top 50 HIF Inhibitors Translational Translation drug safety for product in late preclinical for treatment of anaemia in CKD. Internal Medicine
Top 50 PI3K Inhibitors Translational Research for potential DDI Interactions and risk profile for PI3K inhibitors. Oncology
Top 50 Analgesic Translational To facilitate preclinical to phase I for a product in neuropathic pain. Pain
SME Nitrite (inhaled) Translational Setup Eudravigilance reporting , review of narratives, processing and reporting of SAE/SUSARs and line listings and prep and submission of DSUR. Respiratory
SME Inhaled Biological Translational Review of PK and safety date from ongoing FIH study. Respiratory
SME Inhaled IFN Beta Translational Medical monitoring and total pharmacovigilance and systems management. Respiratory
Company Product Phase Indication and Service Therapeutic Area
Top 50 Anti Tuberculosis Phase III Preparation of and defence of MAA including drug safety. Infectious Diseases
Top 50 Antibiotic Phase III Writing of new antibiotic MAA including 2.7.4 and 2.5 and Risk Management Plans and defence support to successful license. Infectious Diseases
Top 50 Antifungal Phase III To facilitate discussions and decisions on the labelling and support MAA and defence questions at D120. Infectious Diseases
Top 50 Antibiotic Phase III Preparation for and defence of MAA including drug safety. Infectious Diseases
Medium Antibiotic Phase III Writing of new antibiotic MAA including 2.7.4 and 2.5 and defence support to successful license. Infectious Diseases
Medium Antibiotic Phase III DDRMP and setting up of drug safety systems. Infectious Diseases
Medium Phosphate Binder Phase III Design of protocols and development protocol and responsible person for the high morbidity ACT studies. Internal Medicine
Top 50 Phosphate Binder Phase III MAA /NDA and defence for new product. Internal Medicine
Top 50 Iron Compound Phase III AE Narrative writing. Internal Medicine
Medium NA Phase III Interim Director Pharmacovigilance, Oncology. Oncology
Medium Novel Oncology Compound Phase III Review of CIOMS I and narratives for Phase III clinical trial. Oncology
Not Pharma Monoclonal Antibodies Phase III Medical monitoring plans and medical monitoring. Oncology
Medium Corticosteroid Phase III Preparation and review of MAA documents including safety section and clinical overview. Respiratory
Medium Surfactant Phase III Update Risk Management Plan. Respiratory
Company Product Phase Indication and Service Therapeutic Area
Medium Antibiotic Launch Identification and review of UK pharmacoepidemiological databases for supporting proactive risk management. Infectious Diseases
Medium Antibiotic Launch Development of PSUR template, SOPs and Risk Management Plan. Infectious Diseases
Medium Antibiotic Launch Setting up a Training Centre for MSLs including drug safety training. Infectious Diseases
Top 50 Analgesic Launch Medical monitoring of topical drug safety pain product. Pain
Medium 9 Mature Products Mature Support for Article 31 Oral hearing and related activities risk benefit activities and risk management plans. CNS
Top 50 Parkinson's Mature PBRER, clinical overview and CDS updates. CNS
Top 50 Benzodiazepine Mature PBRER and CDS update, PSUR and cross functional review of drug safety reviews. CNS
Top 50 Benzodiazepine Antagonist Mature PBRER and CDS update. CNS
Medium Antibiotic Mature Preparation of generic submissions and regulatory defence for harmonisation and risk management plan. Infectious Diseases
Top 50 Antibiotic Mature EU SmPC harmonisation drug safety. Infectious Diseases
Top 50 Antiviral Mature PBRER and article 30. Infectious Diseases
Top 50 Antiviral Mature Benefit risk assessment. Infectious Diseases
Top 50 Antiemetic Mature EU SmPC harmonisation drug safety. Internal Medicine
Top 50 Biological Anti-inflammatory Mature PSUR Input/preparation and other pharmacovigilance tasks as requested. Internal Medicine
Top 50 Immunosuppressant Mature PBRER. Internal Medicine
Top 50 Oncology Biological Mature Oversight of all pharmacovigilance for biological oncology product and overall safety science. Oncology
Top 50 Monoclonal Antibody Mature Support the MAA and NDA submission and responses for a new indication for an oncology biological. Oncology
Medium Various Mature EU QPPV. Other
SME Various Mature QPPV Services. Other
Top 50 Pain Mature PBRER, DSUR and associated documents. Pain
Top 50 NSAID Mature PBRER. Pain
Top 50 Antiviral Mature Review of risk minimization plan, including gap analysis and enhanced process for Risk Management Plans. Infectious Diseases
Top 50 NA NA Communicating Benefit Risk Information to the Public for a large pharma. Other