Pharmacovigilance Services

A Serious Adverse Event (SAE) Data-Capture system is critical for any project. With our Safety Management System, safety data is at your finger tips and is maintained in a tightly controlled, monitored database. Your data will be available for safety personnel to review at any time, world-wide. The system itself is role based and allows each client to customize their process flow whether you want the QDS Safety Team or your own to interact with sites and regulatory authorities for the collection and reporting of SAEs.

Safety Managers

Our Safety Team is comprised of nurses and physicians with years of clinic and industry related experience. The team uses the Safety Management component to manage all of your safety information needs. Our experienced staff is dedicated to collecting initial information, and all required follow-up information, for complete safety services, while their responsive nature allows for real time-decisions.

Safety Services

  • Coding of Adverse Events (AEs), Medications and Medical History in MeDRA, WHOART, NCI, and WHODrug, Clinical and Patient Profile Review as requested by the client
  • Auto-generation of MedWatch and CIOMS reports
  • Narratives
  • Integrated Summary of Safety Review for signal detection

Medical Monitoring Services

  • Pre-Screen Subject Eligibility
  • Review of Clinical Laboratory Data
  • Review and Follow-Up of SAEs
  • Review of Concomitant Medications, AEs and Medical Coding

Process

Process

Clinical Safety Data Management

The Importance Of Pharmacovigilance Consulting Services

Researchers conducting clinical trials to test the efficacy of treatment and drugs often rely on pharmacovigilance services, specialist organizations that provide third-party clinical safety data management. Pharmacovigilance solutions include the collection, monitoring, analysis, and prevention of adverse events, such as instances in which the life of people in the clinical trial is at risk. Safety services, therefore, are vital for site monitoring clinical trials.

Testing a new drug or candidate molecule is fraught with dangers. Safety managers are usually unable to model the way that the intervention will interact with the treatment in advance. Clinical risk management enhancing patient safety provides a way to buffer against these risks, but they are not perfect. Pharmacovigilance services, therefore, use safety data as a form of defense. Safety management monitors adverse effects from drugs, molecules, drug interactions, dosages, and so on to provide warnings to researchers ahead of time if they risk harming study participants. Our team has experience in biostatistics SAS programming, allowing us to offer pharmacovigilance solutions that can detect, record, analyze, and predict potential adverse outcomes.

Additional Information

The Benefits Of Pharmacovigilance Services

Pharmacovigilance services are arguably among the most important in the entire life sciences community. Companies, research labs, and academic institutions must adhere to rules for clinical risk management enhancing patient safety. If they don’t, they could find themselves facing fines, legal action, and defunding.

Clinical safety data management is all about ensuring that researchers follow the rules and protect patients. Our safety managers put robust solutions in place that make sure that you collect all of the data that you need.

There are many benefits of using our pharmacovigilance consulting services.

Enhance Drug Safety

Drug development companies need to ensure that their operations keep moving. Hold-ups can cause delays and force you to shelve projects. Clinical safety data management and pharmacovigilance services help you to avoid safety issues that lead to the shutdown or postponement of a clinical trial. With our safety management expertise, you can keep the wheels moving and potentially faster development cycles with fewer delays.

Stop Developments Early

No pharmaceutical company or research team wants to have a patient safety issue on their hands. Pharmacovigilance consulting services, therefore, not only help you evaluate your patient safety data, but also have the authority to shut down a trial if there are serious safety issues on the horizon. Safety services, therefore, become a significant component of your clinical safety data management, reducing the risks to patients and damage to your brand.

Higher Patient Safety

Clinical risk management enhancing patient safety is vital for the successful outcome of stage one and stage two clinical trials. Pharmacovigilance consulting services help to achieve higher levels of patient safety throughout the drug development cycle, including the point at which the drug becomes available on the market. Pharmacovigilance services provide ongoing support, from the initial inception of the clinical trial to the final implementation of the drug in the market. Safety managers monitor the data from beginning to end, looking for possible adverse effect risks and deploying pharmacovigilance solutions to prevent them from materializing in a damaging way.

How Do Our Pharmacovigilance Consulting Services Improve Safety

Pharmacovigilance solutions cover a broad range of safety management sub-specialisms.

One of the primary functions is surveillance. This is where pharmacovigilance consulting services use data management in clinical research to look for signals that might indicate risk. People who work in this area can possess a range of titles and are qualified to create reports, gather information, and review aggregates of information. They are also responsible for creating development safety update reports found commonly in the world of clinical research.

Another sub-discipline is operations. This is where we collect data on the ground, recording information related to preclinical development and clinical trials. It is also the method by which we collect “real-world evidence” of adverse events, allowing the producers of drugs to provide accurate information on common and rare side-effects.

The third area of assistance we provide comes in the building and development of robust systems to enhance patient safety in clinical trials. This includes not only data collection protocols but digital data management, storage, archiving, and collating data from third-party vendors. These systems need to go through a process of continual improvement as standards in the life sciences community continue to evolve.

As legislation continues to change, drug companies, research labs, and individual researchers need safety management services that protect both them and their patients. Use QDS today for customized safety services with real-time decision-making.