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

pharmacovigilance servicesThe 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.

Our Clinical Risk Management Services Enhances Patient Safety

Pharmacovigilance Consulting

Clinical safety management is a vital part of any clinical trial. Yet with so many different parts of a trial occurring at the same time, it can be easy for safety regulations and other aspects of safety to fall by the wayside. This could result in delays and punishments further down the line. To ensure you have proper clinical safety management, you need the services of QDS. Here is everything you need to know about our clinical risk management enhancing patient safety.

clinical risk management enhancing patient safetyWhen it comes to pharmacovigilance consulting, the best advice is given by those with experience in the field. With over 100 years’ worth of experience, no one can give better advice than we can. Our staff has been working with pharmacovigilance strategies for years. We have fine-tuned the necessities for clinical risk management enhancing patient safety.

Some solutions you can expect from us are:

  • 24/7 Medical Monitoring coverage
  • Pharmacovigilance case processing
  • MedWatch or CIOMS production
  • Narrative writing
  • DSMB management and participation
  • IND annual reporting
  • Clinical Review
  • Patient Profile review

There are several benefits you can enjoy when you choose us for clinical safety management. One of the most important is improved safety. We go over all of the regulations and guidelines to ensure your study is in full compliance. With our help, safety will not be overlooked.

We also make sure your trial stays on track according to your schedule. Those who don’t adhere to safety regulations are often forced to wait and delay their trials until the proper safety measures are put into place. We can ensure those safety measures are already in force before your trial begins. You will not experience any delays and can get right to work.

Others might experience monetary punishments for avoiding safety regulations. We will ensure that you stay on budget by adhering to all regulations to avoid penalties.

Contact Us Today

If you’re ready for one of the best and comprehensive safety management service, then contact our team today. We will keep your trial going smoothly and safely for everyone involved. Give us a call to learn more.

Clinical safety data management and pharmacovigilance services are essential to avoid any safety issues that can result in the postponement or shutdown of clinical trials. Aside from this, clinical safety data management and pharmacovigilance services are also important to ensure patient safety and the continued vigilance of their wellbeing.

For businesses operating in the healthcare industry, investing in these services is crucial to their operations. That’s why the team behind Quality Data Service, Inc. is here to help. We’ve been providing pharmacovigilance solutions and pharmacovigilance consulting services to the healthcare industry for decades, making us one of the best service providers.

Why We’re Different From Others

Many companies offer pharmacovigilance solutions, but we’re confident that ours is the best. Aside from being in the industry for decades, we also use tried and tested practices in clinical risk management and enhancing patient safety. Our pharmacovigilance solutions ensure that your data is tightly controlled and regularly maintained through a secured database.

When you choose our pharmacovigilance solutions, you’ll have peace of mind knowing that your data is secured yet available for review any time worldwide. We use a system that allows clients like you to customize your own process flow, making it easier for you and your team to collect and report a Serious Adverse Event (or SAE).

Why You Should Trust Our Safety Managers

Our pharmacovigilance consulting services are conducted by a team of expert safety managers. This team is composed of nurses and physicians who have years of professional experience in the healthcare industry. Our team only uses flawless methods of clinical risk management in enhancing patient safety and has the necessary tools to collect information.

Our safety managers can also accomplish the following tasks:

  • Creation of narratives and integrated summary of safety reviews
  • Coding of Adverse Events
  • Pre-screening subject eligibility
  • Reviews of clinical laboratory data
  • And more!

What You Can Expect From Us

With years of professional experience, we’re confident that we can help improve your processes. Our team has been perfecting pharmacovigilance solutions, and we’re ready to share these strategies with you.

We understand how vital clinical safety management is, and our team is here to ensure that your clinical trials don’t lead to delays, punishments, or even legal repercussions. Our pharmacovigilance consulting services will guarantee that your clinical trials follow safety regulations, so your team can focus more on evaluating a behavioral, medical, or surgical intervention.

Some solutions you can expect from our team are:

  • 24/7 medical monitoring coverage
  • Comprehensive narrative writing
  • Participation of the Data and Safety Monitoring Board or DSMB
  • Patient profile reviews
  • Clinical reviews
  • And so much more!

Contact Us Today

If you’re curious about our offerings and how we can help your clinical trials, contact us today. You can reach us at 610.354.0404 or send us an email through info@qdservices.com. We are open from Mondays to Fridays, from 8:30 AM to 4:30 PM.

We’re looking forward to hearing from you and working with you soon!