We can assist with designing the pharmacovigilance processes and creating the SOPs required to setup a new drug safety operation. We have experiences in setting up of best practice PV SOPs with both small medium and large pharmas. We have experiences in implementing business processes and system workflows for small to medium sized businesses and can also provide hosted safety systems.

PBRER, PSUR, DSUR: We have plenty of experience in the preparation of the PBRER and PSURs. We have been involved in the production of Developmental Safety Update Reports (DSURs) for clients as part of internal safety reviews and to provide documents that mirror the post-marketing PSURs/PBRERs.

Risk Management Plan: We can provide full support in writing up risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS)

We can perform searches and review your literature on a weekly or ad hoc basis. We can screen literatures relevant for ICSRs, Aggregate reports, Articles of special interest

Signal Management is a critical process of Pharmacovigilance required by EU Good Pharmacovigilance Practice. It is the scientific component that underpins Pharmacovigilance, and the very reason why Pharmacovigilance was created in the first place. We have the full capacity in providing end to end signal management service. We have experience in providing services from small, medium and large pharmaceutical companies

If you would like to have control over your safety data but do not want the cost and delay of setting up a compliant safety processing system, we can support you on this. We can set up and host your safety database and write your SOPs. If you want to outsource any part of the adverse event management process we can help you as needed. Our ICSR Processing system is supported with a fully E2B and CFR21 Part 11 compliant database, which has an integrated submission management tool for direct submissions, complex search functionality and simplified signal detection. It enables E2B-compliant XML file import and export, recording of Individual Case Safety Reports (ICSRs) and the generation of:

• CIOMS I format reports
• MedWatch format reports
• Line-listings
• Summary tabulations

We support sponsors in clinical research with the services of high-quality safety data processing, handling and reporting, including:

• Safety management planning
• Adverse Events processing, including recording in Safety Database
• MedDRA coding
• Narrative writing
• Medical data review
• SUSARs handling
• Aggregate reporting

With our wide Local Safety Officers (LSOs) network, SIKDAR CONSULTING can fulfil all and any local Marketing Authorisation Holder’s obligations in EU and non-EU countries and perform all local pharmacovigilance representation activities, including:

• Appointment of Lead LSO and Deputy LSO for each country and their nomination to the local Competent Authority;
• 24/7 availability, where required;
• Weekly monitoring of locally published scientific and medical literature;
• Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable;
• National regulatory intelligence;
• Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
• Delivery of pharmacovigilance trainings to local Marketing Authorisation Holders personnel.