One thing's permanently paramount: the well-being of our patients

Patient safety is a central aspect in any stage of clinical research and the primary measure required for this purpose is the adequate processing of any reported adverse event (AE) and potential side-effect. Prompt and profound medical assessment of such safety reports is the basis for expert surveillance of the trial’s benefit/risk-ratio and for the protection of the participating patients. The fulfillment of regulatory requirements indicates a qualified and accurate management of individual case safety reports.

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We offer full-services Safety and Pharmacovigilance solutions for each step in planning and conducting all phases and types of clinical trials. Our team manages the study relevant safety data and presents if required by regulatory standards clear and comprehensive annual Data and Safety Update Reports (DSURs) and Safety Summary Reports (SSRs) to study-related Data and Safety Monitoring Boards (DSMBs) – competent groups of independent experts external to the trial. DSMBs convene at periodic intervals and their establishment and management are clearly prescribed by a specific charter developed by palleos.

 

Self-dependently validated systems and processes that meet state-of-the-art quality standards and fulfill all regulatory requirements serve as the basis to meet your needs and expectations. Our highly qualified and experienced team continuously ensures proficient, reliable and stable case management and ongoing data analysis while our internal quality management ensures the constant improvement of advanced workflows. Easily accessible individual contact offers quick and expert, solution-orientated assistance to support you and to make a success of your sophisticated projects.

Our Safety & Pharmacovigilance services include

Safety Management Plan

Setup

MedDRA coding expertise (MSSO-certified coding specialists)

Setup

Execution

Comprehensive Case Management

Execution

Supervision through additional Safety Review Committee (SRC) for Phase I

Execution

Safety oversight service

Execution

ICSR processing in clinical trials (Phase I-IV including NIS)

Execution

Medical assessment of ICSRs

Execution

Regulatory reporting to authorities, investigators and ethics committees

Execution

Electronic safety reporting via EudraVigilance

Execution

Medical review of individual and cumulative subject data

Execution

Development Safety Update Report (DSUR)

Execution

Preparation of tabulated safety data for DSMBs and MAHs

Execution

Post-marketing surveillance (observational studies, spontaneous reports)

Development

Setup

Execution

Closure

Experience in the use and maintenance of eDrug Safety solutions (i.e. VigilanceONE, PcVmanger) including data retrieval and reconciliation, compliance monitoring and user training

Development

Setup

Execution

Closure

Learn more about

Clinical Trials

 

“Every trial is unique and mondane. We work with you to manage both.”

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