Pharmacovigilance

Pierrel Research offers a comprehensive portfolio of services for the active management of product safety and patient health during the entire lifecycle of a product, helping you manage your pre- and post-marketed product safety program.

Our global reach, quality system approach, leading technology for SAE and AE cases management and reporting, combined with a multi-disciplinary safety expertise offers true value and key benefits to pharma, biotech and device companies.

Pierrel Research is your strategic partner with specific product safety expertise who can minimize your current cost pressure while unlocking value and maintaining compliance.

Pharmacovigilance Services

• Adverse event (AE) and serious adverse event (SAE) data collection, logging , tracking , coding and case processing
• MedDRA and WHO-DD coding
• Web-based SAE reporting tool, Hyper-eSAE® for immediate SAE notification from clinical trials
• AE and SAE evaluations
• SAE narrative writing
• Physician medical review and signal detection
• Literature reviews and summaries
• Generation of CIOMS I /MedWatch 3500A forms
• Preparation of Annual Safety Reports from clinical trials
• Expedited reporting to competent authorities, ethics committees and investigators
• Electronic expedited reporting via EVWEB, provision of Responsible Person for EudraVigilance and certified users for EVWEB
• Electronic expedited reporting of Individual Case Safety Reports
• Preparation and submission of PSURs
• Development of Risk Management Plans
• Set-up of the pharmacovigilance system of MAH/applicant for marketing authorization
• EU QPPV/deputy QPPV
• Web-based, ICH E2B- compliant safety database, HyperVigilance®, validated in-line with GAMP 5 and 21 CFR 11

Medical Monitoring

Medical monitoring is provided by licensed physicians who have extensive experience in clinical development and review of SAE and AE cases.

• Assessing subject eligibility
• Evaluating study protocols and informed consents
• Analyzing and reporting serious adverse events (SAEs)
• Tracking participants’ safety throughout the trial
• Assessing the benefits and risks on an ongoing basis
• Identifying safety signals and safety trends

Medical Consulting

Our medical experts will help you develop effective strategies to making accurate safety assessments to ensuring regulatory compliance in your medical reports. Together with the regulatory team, they will help you design appropriate clinical trials and ensure an efficient regulatory submission strategy to expedite your product approval and commercialization. Our medical consulting services include:

• Strategic planning throughout the registration process
• Strategic planning in the designing of efficacy and safety clinical trials
• Assessing regulatory compliance of the product development plan
• Identifying safety signals and determining significance
• Developing Pre-registration meeting packages
• Providing medical review of your safety data
• Providing benefit-risk assessments