Biopharma Companies

Our experienced and knowledgeable PV team offers a wide range and high-standard expert consulting and contract team services to assist our clients in enhancing their safety procedures, operations.

Why Pharmacovigilance Expert Consulting and contract team services?

  • Pharmacovigilance is fundamental to the industry due to following reasons:
  • The increasing concern by regulatory authorities of accurate and timely reporting of Adverse Events
  • Pharmacovigilance staff plays an important role in expedited reporting of individual cases and safety updates
  • The increasing inspection by regulatory authorities of Adverse Events coming from non-clinical trial sources such as non-interventional or patient assistance programs
  • The increasing usage of social media and industry sponsored websites to highlight safety data
  • There is high cost to set up and maintain the needed infrastructure to support an internal pharmacovigilance team
  • There is a challenge to recruit and retain qualified personnel to staff an internal PV team scale up the operations

Expert Consulting Services

1. Clinical Trails

  • Medical review of individual case reports (e.g., AE, SAE, ESR, SUSAR)
  • MedDRA Coding, WHO Drug Coding
  • Periodic or Ad Hoc Aggregate Safety Reports:
  • Product safety profile assessment and key safety issue identification
  • Aggregate safety data search and summary strategy
  • Overall risks / benefits assessment
  • Safety signal detection and integrated review of clinical trials safety data across protocols or programs
  • Risk management planning and related PV activities (PSUR, PBRER, CCDS/product labeling update, safety studies)
  • Development of reference safety information and company core safety documents (including DCSI, IB)
  • Review and recommendation of safety sections in the clinical study reports and integrated clinical safety summary (e.g., SCS, ISS).
  • Development of safety related clinical trial documents (e.g., protocols, CSR, IB, CRF, ICF, SMP, MMP, SAE form).
  • Product medical safety management team building and SOPs monitoring in Phase 1-4 clinical trials; ongoing safety data monitoring
  • Strategic support and consultation for global new drug filings (e.g., NDA, MAA submissions).

2. Post-marketing

  • Post-marketing PV functions, and department, and team building
  • PV medical safety assessment trainings, PV SOPs/ WIs/ templates development
  • PV database and PV system updates
  • Published literature review strategy
  • Safety signal detection and data mining (e.g., MGPS) and risk management update
  • Development and updates CCDS safety and local labels.
  • PV audit and inspection
  • Assessment and management of product quality issues and product recalls/withdrawal.
  • Safety regulatory reporting and submission
  • Safety data exchange agreement (SDEA) development
  • Establish and manage safety related off-shore and outsourcing models and activities.

3. PV-DM

  • Safety database data listings and reports development
  • Signal detection data integration (e.g. : EDC and safety database) and review support

contract team services

1. Clinical Trails

  • ICSRs case processing (ICH E2B Standard)
  • Medical review of individual case reports (e.g., AE, SAE, ESR, SUSAR); MedDRA Coding, WHO Drug Coding, narratives writing, query tracking, targeted follow-up
  • Aggregate Safety Reports:
  • Periodic safety update reports (e.g., DSUR, IND Annual Report)
  • Safety signal detection Labs, ECG, Holter Data Summary, development of targeted questionnaires for AEoSIs, integrated review of clinical trials data across protocols or programs, and pharmacoepidemiology review.
  • Risk management planning and development (e.g., EU RMP, US REMS); risk data summary, risk minimization activities, ongoing evidence-based risk/benefit assessment
  • Development of company core safety documents (including CCDS) and local labels.
  • Review and development of safety sections in the clinical study reports; preparation of integrated clinical safety summary (e.g., SCS, ISS).
  • Medical safety monitoring in Phase 1-4 clinical trials; ongoing safety data monitoring and assessment of potential new and unexpected safety signals.
  • Development of safety data integration summary and reports for NDA, MAA submissions

2. Post-marketing

  • Post-marketing AE/SAE case processing
  • Published literature and pharmacoepidemiology review
  • Aggregate safety report development
  • Periodic safety update reports (e.g., PSUR, PADER, PBRER, ASR, Summary Bridging Report, Addendum)
  • Ad Hoc Safety Reports (e.g., Clinical overview/summary for labeling update, Safety expert report for assessment of safety queries)
  • Other reports (e.g., Medical impact analysis (MIA) reports, Safety summary, Customized line listings and summary tabulations for aggregate data)
  • Safety signal detection and data mining (e.g., MGPS) reports
  • Ongoing evidence-based risk/benefit assessment and RMP update

Contract Team Solutions

1. Customized Services

Safety Tasks are not all the same, so our wide range of skilled team members are ready to provide tailored solutions to your company. We specialize in completing specific safety tasks no matter how complex. 

  • Labs/ECG data summary for safety monitoring and signal detection 
  • medical impact analysis for late SAE reports 
  • published literature review and summary 

2. Comprehensive Services

With a stable of seasoned professionals ranging from safety physicians to database managers, we are prepared to assist in all stages of trials and research.

  • full clinical safety services for clinical trials including SAE processing 
  • medical safety monitoring 
  • signal detection
  • DSUR
  • IB update 
  • CSR safety section

3. Team Integration Services

Our professionals are trained in the latest regulations and processes, which allows them to seamlessly assist your existing safety team to achieve safety goals.

We provide experienced medical safety professionals to work alongside your safety team in order to meet your special safety evaluation needs.

  • G2 medical reviewers working in our clients’ ICSR processing teams, 
  • G2 medical scientific writer working with our clients’ safety physicians on DSURs or PBRERs