Pharmaceutical

Drug Safety

Our team of medical and clinical experts includes physicians, pharmacists and PhDs with a broad combined industry and clinical experience. This experience coupled with expertise in pharmacovigilance and drug safety allows us to provide you with quality safety services, including comprehensive safety data management, and report preparation.

1. Clinical Trial Safety

We have proven processes and systems in place for managing reports of Serious Adverse Events (SAEs) or non-serious adverse events in international clinical trials. We offer to process your safety data in your database, or in a customized database at our end, following your SOPs or customized SOPs in a consistent and accurate way. Our services include the following:

Triage

• Assessment of seriousness/expectedness

Data Entry

• Data entry according to CRF or SAE report form

• Extraction and coding

• Narrative development
   

Medical evaluation

• Verification of medical integrity of narrative

• Verification of coding

• Causality assessment

• Determination of expectedness

Queries and follow-up

• Systematic query in case of missing data element

• Medical query in case of missing medical elements

Quality control (QC)

• Full data check against source document

• Medical QC of causality assessment

• Medical QC of event coding and term extraction

Regulatory submission

• Directly to regulatory authorities

2. Post-Marketing Safety

We have proven processes and systems in place for managing Adverse Drug Reactions (ADR) from spontaneous sources including health care professionals, consumers, literature and other databases. We offer to process your safety data in your database, or in a customized database at our end, following your SOPs or new SOPs in a consistent and accurate way.

3. Safety Reports

At Wability we have prepared many Periodic Safety Update Reports, and other regulatory safety reports in line with the International Conference on Harmonisation (ICH) guidelines or local regulation, for several leading pharma companies. Our broad experience in drug safety and medical writing allows us to offer you the following services:

• Periodic Safety Update Reports

• Summary bridging reports

• Expert statements

• Addendum reports

• Review of PSURs or other safety documents prepared by companies

• Specific authority requests

4. Consulting Services

Wability offers ad-hoc/temporary support or comprehensive review of your pharmacovigilance system, including SOPs, training, etc. Our services include, but are not limited to:

• Preparation/review of pharmacovigilance contracts with your license partners

• Preparation of CDS

• Pharmacovigilance process assessment

• Literature review

• Training in all aspects of safety and pharmacovigilance

• Data entry in a fully validated database

• Reporting to the health authorities

• Electronic reporting

5. Medical Monitoring and Medical Consulting Services

Using only experienced Medical Doctors with extensive experience in drug Safety and clinical research. Wability provides a complete range of medical monitoring and medical consulting services, including:

• Providing 24/7 Physician Coverage

• Determining Subject Eligibility for Clinical Trials

• Reviewing Study Protocols and Informed Consents

• Reviewing Serious Adverse Events (SAEs)

• Performing a Medical Review of NDA/Registration and Clinical Study

• Analysis of Medical Product Safety Protocol

• Benefit-Risk Assessments

• Identification of Safety Signals

• Assist in Response to Regulatory Authorities Regarding Safety Issues

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