The Importance of Pharmacovigilance
Pharmacovigilance
Pharmacovigilance is a critical aspect of drug development and post-market surveillance. We have a deep understanding of the necessity of staying up to date on safety concerns and regulatory requirements.
ECNE Research offers comprehensive pharmacovigilance services to ensure product safety and regulatory compliance throughout the product lifecycle. Our services include safety signal detection and management, adverse event reporting, case management, the preparation of aggregate safety reports such as PSURs, DSURs, and PBRERs. We also develop and maintain risk management plans to proactively address product risks, helping our clients navigate complex safety regulations with confidence and prioritize patient safety.
We also support medical literature monitoring. Our literature reviews are meticulously conducted to provide you with timely literature reports to support your pharmacovigilance requirements.
PSURs and DSURs: The guardians of drug safety
Two Crucial Documents
PSURs and DSURs: The guardians of drug safety, ensuring patient well-being throughout a drug's journey.
These crucial pharmacovigilance reports act like watchdogs, monitoring safety at every stage. PSURs keep a watchful eye on medications once they reach the market, identifying any new risks. Meanwhile, DSURs diligently track safety concerns during development.
Both PSURs and DSURs are mandatory for regulatory compliance. They play a vital role in ensuring the benefits of a drug outweigh the risks for patients. By providing a comprehensive picture of drug safety, these reports ultimately contribute to the well-being of countless individuals who rely on these medications.
SERVICE DELIVERY
The ECNE Approach
Project Management
The ECNE Approach
Part of our commitment to a client is to proactively help you achieve your mission and project goals by providing customized solutions for your clinical and scientific needs.
We are focused on quality and efficiency and provide customized deliverables while supporting your team to improve processes, ultimately improving efficiency and reducing costs.
We will maintain frequent communication to ensure we are delivering value. Our team are available to meet with you in person or virtually to discuss initiatives and concerns and to provide you with the latest industry updates.
4-Phase Process
Project Management
The ECNE Approach
Our process for providing high-quality deliverables includes 4 phases:
- Phase 1: Pre-planning
- Phase 2: Acceptance
- Phase 3: Execution
- Phase 4: Completion
We become a trusted partner, listening carefully to understand your needs and then developing a detailed plan that will ensure your goals are fully met, delivering on time and within budget.
Project Management
Project Management
Project Management
Once you choose ECNE Research as your clinical partner, and an expert in medical writing, we will create a comprehensive project management plan.
We use a variety of software solutions to ensure projects run efficiently and are delivered on time. As a client of ECNE Research, you will be able to avail of our technology-enabled solutions that enhance accuracy, precision, and efficiency of evidence generation and clinical document creation.
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