Safety Evaluation & Risk Management

Our medically qualified team with hands-on experience on signal management and risk minimization activities provides strategic medical support across various therapeutic areas.

Safety Evaluation & Risk Management Services

  • Screening, data mining and comprehensive review of safety data available from various sources
  • Qualitative and quantitative analysis of potential signals
  • Preparation of safety signal surveillance reports
  • Development & review of Risk Management Plans
  • Strategic advice on effective safety monitoring activities
  • Authoring and development of components of REMS (risk evaluation and mitigation strategies), additional risk minimization measures with emphasis on ETASU (elements to assure safe use)
  • Evaluating the effectiveness of additional risk minimization measures
  • Periodic review of the effectiveness of one or more specific tools or the overall programme
  • Quality, accuracy and scientific integrity of the proposed measures

Other Drug Safety Services

Case Processing

We provide end to end (E2E) Pharmacovigilance and Clinical Safety services to Pharmaceutical, Biotechnology and Medical Device companies.

Clinical Safety

We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials.

Global Literature Search & Management

Sitero offers medical literature monitoring services by well trained and highly experienced literature experts.

Aggregate Safety Report Authoring

Sitero offers comprehensive, concise and critical analysis of the risk-benefit balance of the medicinal products.

EU & UK QPPV and/or Responsible Person (RP) Services

To be compliant with GVP Module-I, Sitero can offer to its customers EU & UK QPPV & RP services by duly experienced and qualified personnel with 24X7 availability to comply with EU & MHRA regulations.

Additional Services

Sitero provides wider range of other support services. We provide best-in-class one-stop solutions to our clients: regulatory intelligence, pharmacovigilance master file (PSMF) Creation & Maintenance, XEVMPD / Article 57 Database Maintenance and PV SOPs Authoring & Maintenance Support.