Ensure Your Project Runs Safely & Effectively With The Help of Our Clinical Management Services

Our office-based Clinical Project Management staff has many years of clinical experience and industry knowledge to ensure your project runs effectively and efficiently.

Our Project Managers understand our clients’ reliance on effective communication and quality. A dedicated Project Manager is assigned to run each trial from start to finish.

From Inception to Completion:

  • Dedicated Project Manager
  • First-line site management
  • Proactive issue identification and corrective action planning
  • Overall responsibility for quality, timelines, budget adherence
  • Performs as a member of your team

Why Contact Us for Clinical Management Services  

Clinical monitoring services can help your organization avoid costly lawsuits and keep people safe. Placing separate companies to monitor your company’s clinical trial, allows for greater transparency while taking part in a medical device market research trial. You will have more information about your trial participants’ condition than if you were relying on yourself and other employees to monitor the rest of it. We are here for you if you are looking for quality pharmaceutical drug trial monitoring services!

Make Sure Your Projects Run Safely and Effectively With The help of Our Clinical Management Service

As the leading service provider in the clinical management services industry, our team helps several industries and companies with infrastructure-related projects. Here are three ways we can make sure your projects run safely and effectively with the help of our clinical monitoring and management service.

1) We have several options to suit any project, size or complexity, and budget to help you undertake medical device market research.

2) Our on-time guarantee keeps you worry-free as you can always count on our clinical research monitor to deliver results within your specified timeframe.

3) Our experienced staff, in collaboration with our clinical trial manager, can work flexible hours so you can get back in touch when needed even if we are already working and be assured that we will not neglect any critical task during our shift changeover time frame.

Further, to ensure that your project runs effectively and safely, we offer different services such as:

Services Include:

  • Site Qualification Visits
  • Initiation Visits
  • Interim Clinical Monitoring Visits
  • Study Close Out Visits
  • Drug Accountability
  • Site Management

Our Process

  • Site Feasibility Assessment
  • Investigator Assessment
  • Establishment of Operations Manual
  • Communications & Monitoring Plan Development
  • Source Document Creation
  • Site Qualifications
  • Regulatory Document Collection and IRB/EC Submissions
  • Third-Party Vendor Selection
  • Investigator Meeting Presentations
  • Site Initiations
  • Clinical Supply Distribution
  • Oversight of Study Team
  • Site Management and Monitoring
  • Proactive Issue Identification
  • Corrective Action Planning
  • Newsletters and Study Updates
  • Evaluation of Clinical Data
  • Financial Oversight and Management of Study Budget
  • Grant Payments
  • Regulatory Document Maintenance
  • Ongoing Site Training
  • Assistance with Query Resolution
  • IP Accountability & Return/Destruction
  • IRB Close Out Reporting
  • Close Out Monitoring Visits
  • Regulatory Document Reconciliation

Are You Looking For On Site Clinical Trial Management?

clinical monitoring

On-site monitoring of clinical trials is a valuable source for understanding what treatments work best for patients. Our clinical trial manager uses them to help inform new therapies, improve treatment on existing ones, and provide data to support their use. We continue to innovate our approach as we deliver cutting-edge solutions that enable you to give patients the best care possible. Our staff’s expert knowledge in precision medicine will help you optimize your trial execution strategy. That means increased savings in time and money while improving patient outcomes.  

Benefits from our clinical trial site management services:

Additional Information

clinical trial manager

  • Set Up Your Study From The Start And Save Time And Money

Preparation is key to success in site monitoring clinical trials. Our subject recruitment team and study coordinators will work with you to help determine the best way to reach your patient population and successfully execute your trial protocol. Our clinical trial manager has extensive experience recruiting patients for Phase I, Phase II, Phase III, non-interventional, observational studies, and registries. Further, our clinical research project manager can help you recruit in multiple locations simultaneously to reduce costs and logistics and support a variety of trial designs, including parallel-group or crossover designs.

  • Turn Trial Data Into Protocol-Driven Decision-Making

Our data analysis and biomarker development expertise will help you interpret and make recommendations based on your clinical trial site management data. Our clinical research monitor can offer you advanced quality monitoring tools that can help you manage the clinical trials process while helping you develop actionable insights. Continuous quality improvement workshops and team meetings coordinated by our clinical research project manager will help your organization stay competitive. We have a patient safety hotline to ensure members of your research team remain committed to safety management.

  • Customize The Trial Design For Your Study

Our clinical trial manager can help you with sample selection strategies, patient engagement strategies, and customized recruitment materials to optimize research ethics board (REB) approval and site logistics. We provide data management services for investigators and study sponsors to help them understand and select the most appropriate trial design to support your development strategy.

  • Anticipate Your Study Timeline

Our clinical trial manager will work with you to determine an accurate timeline for enrolling each subject, estimate timelines for vendor selection, and help determine potential risks associated with a clinical trial site management start-up, drug trial, and how to mitigate those risks. Through our medical device research and development services, we will also help you manage site contracts, billing, patient scheduling, and recruitment activities, support cross-functional project teams, and much more.

  • Compliance That Helps You Focus On Your Research

There are many regulatory requirements during the clinical trial process. Luckily, our clinical trial manager can help you meet the needs to collect and report data compliant. We provide certificates of analysis, help you comply with state reporting requirements in your state, and can assist with other regulatory requirements, such as clinical trial registration, consent, and protection of human subjects.

  • Pharmaceutical Drug Trial Monitoring Services

Our team has been recognized for having the tools, skills, and workforce to reduce human error during pharmaceutical drug trials. With our safety clinical trial monitoring and assessment process improvement capabilities, many organizations are gaining the full benefits of our medical device research and development services. Here are three ways our clinical monitoring services can benefit your company.

  • Potential ROI on Drug Safety Measures

Monitoring clinical drug trials is a critical part of achieving one of the greatest business goals, bringing safe and effective products to market. Our drug safety experts (DSE) are trained professionals who have spent years working with clinical pharmacists and quality control team leaders, learning the ins and outs of clinical drug trials, which are essential for how these trials work and what needs to be done for them to be successful – or not. Remember that an unsuccessful trial can cost companies millions in wasted investments and potential sales losses.

Several factors play a critical role in determining the success of a drug trial. From appropriately trained DSEs to correct and quick emergency response planning and procedures, many actions can be taken to reduce the possibility of an unsuccessful trial. A company’s human resources executives can help reduce risk using various clinical trial management systems by analyzing return on investment. That allows organizations to determine what monitoring processes should be revised or eliminated based on the ROI analysis. With this being said, organizations can use these same return on investment analyses when analyzing clinical trial monitoring services such as ours.

  • Clinical Monitoring of Trial Participants

This has been one of the most common reasons why organizations are turning to us. Many pharmaceutical drug trials are not only testing a new drug on human subjects but also on other medical procedures concerning the medical device clinical research trial. For example, many pharmaceutical companies monitor their trial participants through blood draws, lung function tests, and many other health measures that can be affected by a new drug or medical procedure. These tests need to be conducted with proper training and procedures to yield accurate results.

The safety of trial participants is always our priority, and that is why our clinical research monitor has made monitoring the participants our priority. Our clinical trial management systems are different from pharmaceutical companies, so we have successfully navigated many challenging trial environments. In reality, our clinical research project manager has managed to help many organizations provide the necessary clinical trial monitoring for their participants without adding any extra cost to their budget.

  • Knowledge Transfer

The knowledge gained through clinical drug trials can be precious in improving patient care and business processes. Our clinical trial monitoring experts are well trained in how and why these trials happen, which can be very helpful if they become aware of another similar trial that they may want to learn more about. That is one of our favorite ways organizations benefit from our clinical trial management systems.

We have brought information back to our clients on hospital and trial processes, new medical device clinical research trends, and even how other companies have responded to an adverse event in their trials. Their clinical monitoring pharmacists are always happy to work with us on ways to help make patient care better, which is why we enjoy spending time with them every day.

 

Pharmaceutical Drug Trial Monitoring Services

Clinical Management for All of Your Projects

In the world of clinical trials, it is essential that you remain on budget and on schedule. Yet with so many pieces of the puzzle often working independently, it can be difficult to know the progress everyone is making. Crucial details may be left by the wayside. To ensure your project stays on budget and proceeds according to schedule, you need the experience of Quality Data Services. We have been partnering with organizations for years on their clinical trials and other projects. Here is everything you need to know about our clinical management.

Why Our Clinical Research Associates (CRA) Make a Difference

If you are performing clinical trials, then you may wonder what the advantage is of having a seasoned CRA. You may just want to perform the clinical trial monitoring yourself. However, most organizations fall into a few budgetary and scheduling problems. Being short-handed or falling behind schedule means that your clinical research monitor might have to start taking part in the clinical trials themselves. Our CRA remains a third-party, able to provide consistent contact and continuity on your project.

Our clinical research project managers are among the best because they have years of experience to share. They have been conducting remote clinical trial site management for several years. They understand the processes that clinical trials go through and can provide advice and guidance on how to stay in compliance with Good Clinical Practices and on schedule.

When you need reliable on site monitoring or remote clinical trial site management, we are one of the best clinical trial management companies from which to choose.

clinical drug trialsAnother reason why we are one of the few cutting-edge clinical trial management companies out there is that we offer several e-clinical management systems. We know that not everyone is going to need the full scope of services under the umbrella of clinical monitoring. That is why our unique online clinical trial management system can offer several different solutions. QDR™ is our proprietary e-clinical suite of services consisting of:

Our flexible e-clinical suite can be used in a variety of ways to fit the needs of your study. Use 1, 2, 3 or all components, they interact in an intelligent way to eliminate needless repetition or redundant entry of study information.

Contact us for a demonstration today!

We know that your clinical research is important. That is why we work with our clients throughout the entire process and provide site monitoring services for their clinical trials to ensure their projects are finished on time and efficiently.

There are many benefits you can enjoy when performing your clinical trials with our monitoring service. For one, our clinical trial managers are highly experienced and cost efficient. At QDS, we charge a fixed fee per visit for monitoring services plus traveling expenses.

Sign Up for a Clinical Trial Monitoring Consultation Today

To ensure your drug or device trials are launched on time, give us a call and see how we can help you.

Contact Us For More Information About Our Company

We know that conducting on-site monitoring clinical trials is often a complex and costly exercise for all organizations. That is why we do what we can to make it easier for our clients. Our clinical trial site management services offer a seamless solution that may increase efficiency, improve data quality, and reduce your medical device clinical research trial expenses. With us on your team, there is no need to worry about whether or not you are complying with regulations or trial guidelines; we take care of all of that for you. You can contact us today to uncover more information regarding the clinical trial management systems that we offer.