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.

Benefits of Pharmacovigilance Services

Preventing Harm And Adverse Events

This type of service helps pharmacists notice any potential harm to patients before it escalates. They can also help stop these occurrences from becoming adverse events by taking proactive actions when needed and contacting doctors about changes in prescriptions that would lessen the chance for harm with the help of our clinical safety data management system.

Helping Clinicians Make Informed Decisions About Medication

Pharmacists provide a valuable point of view on what medications do. They also offer a way for pharmacists and doctors to understand each other’s needs and use the information to make better-informed decisions. This approach differs from the typical doctor-patient relationship in which the doctor makes all of the decisions about medications; this is a pharmaceutical professional’s role, especially regarding drug interactions.

Safety Managers For Your Project

Our clinical safety managers are the perfect asset for clinical risk management and enhancing patient safety. Our safety managers are professional experts in preventing clinical errors and improving patient safety. With clinical safety data management, we enable organizations to optimize health care delivery while reducing costs, enhancing the quality of care, and delivering consistent positive outcomes. Our clinical safety manager can be most helpful by sending them a survey before appointing them to carry out your project.

We take the time to get to know our clients so we can pair the right team member for your tasks. Our representative paired with your assignment does not have to be a safety expert. We just require them to be enthusiastic and ethical in their approach to work and safety issues. We strive on your behalf by setting up processes and establishing a reliable clinical safety data management system. However, you will always take the lead in identifying possible risks and managing them effectively.

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

Benefits of Pharmacovigilance Services

Preventing Harm And Adverse Events

This type of service helps pharmacists notice any potential harm to patients before it escalates. They can also help stop these occurrences from becoming adverse events by taking proactive actions when needed and contacting doctors about changes in prescriptions that would lessen the chance for harm with the help of our clinical safety data management system.

Helping Clinicians Make Informed Decisions About Medication

Pharmacists provide a valuable point of view on what medications do. They also offer a way for pharmacists and doctors to understand each other’s needs and use the information to make better-informed decisions. This approach differs from the typical doctor-patient relationship in which the doctor makes all of the decisions about medications; this is a pharmaceutical professional’s role, especially regarding drug interactions.

How Do Our Pharmacovigilance Consulting Services Help Improve Safety?

Pharmacovigilance Consultants Help Make Informed Decisions

The pharmacovigilance practitioner is a critical decision-maker within the healthcare organization. They are often involved with numerous activities that help protect patients from the harmful effects of drugs. Our pharmacovigilance consulting services can help you make sure your organization is compliant and that you have practical solutions for all situations. Our experts are there to ensure that your systems for pharmacovigilance solutions are up-to-date and sustainable so that you can make the right decisions in every case regarding clinical risk management and enhancing patient safety.

Protect Researchers And Doctors

The pharmacovigilance practitioner is responsible for confirming a drug’s safety before it reaches doctors or patients. In the process, they are responsible for monitoring side effects. A pharmacovigilance practitioner can help determine whether a drug should be withdrawn from the market because of the risk of severe side effects. Our pharmacovigilance consulting services are a flexible and cost-effective solution to ensure that you have advice, help, and ongoing guidance to protect researchers and doctors from adverse drug effects.

Encourage Doctors To Properly Prescribe Medications

The best way to keep your medications safe is by ensuring that the correct information about a drug’s safety and efficacy is available for doctors to use when they prescribe medicine. Our pharmacovigilance consulting services help doctors and patients choose which medication is most appropriate for each individual, so you can both feel secure about their choice. We also maintain your r clinical safety data management systems to ensure they are up-to-date and sustainable, which gives you the confidence in knowing the most accurate information is available.

Help Reduce The Cost Of Drug Safety Monitoring

Our cro pharmacovigilance services are a cost-effective solution to ensure your organization is compliant with all of its regulations and that every aspect of drug safety clinical monitoring is done efficiently, effectively, and consistently. We’re committed to meeting our clients’ needs, by providing a wide range of affordable solutions. We want to ensure that both you and your patient feel confident about taking their medications. We recognize the benefits of cost-effective pharmacovigilance solutions, especially for smaller organizations where additional costs can be an issue.

Enhance Patient Safety With Clinical Risk Management Services

Staying competitive in this ever-changing healthcare world demands innovative thinking from all levels of the organization. Our team believes that working together with our clients to achieve success is critical. Our clinical managers create customized programs for clinical risk management enhancing patient safety, whether within the organization itself or in an outside healthcare network.

clinical risk management enhancing patient safety

Our team helps organizations implement strategies that reduce the potential risk of errors, follow up with previous incidents, and measure their current level of CRM. We are patient-focused, and our primary goal is to assist hospitals in minimizing incidents that result in adverse patient outcomes by providing scientifically based risk management strategies custom-tailored to your unique needs. A unique approach to developing and managing specific clinical safety data management programs. A thorough understanding of how your organization’s culture impacts quality care and compliance. You can also expect several safety solutions from our organization when using our cro pharmacovigilance services, including:

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

Our cro pharmacovigilance services are customized to the specific needs of your organization. Our clinical safety data management programs improve safety, meet government and regulatory requirements around quality improvement and help you stay competitive in the healthcare industry. We have the tools to evaluate your current situation and develop a strategy for moving forward in a way that will meet your goals.

Contact Us For More Information Today

Our certified clinical staff can help you meet or exceed regulatory requirements, ensuring that all protocols are followed and improving quality assurance in your clinical workplace. We offer a full range of pharmacovigilance solutions tailored to meet the needs of small business owners, large institutions, and even pharmaceutical companies. No matter what industry you’re in or how big you are, we have the tools and expertise to handle any challenge. Our team of certified experts can help you improve quality assurance in your workplace, meet regulatory compliance and maintain a safe work environment, ensure the accuracy and security of your clinical records and reporting and manage any audit or inspection with ease.

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!