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Patient-centric global research for registries, observational and real-world studies, post-marketing commitments, safety studies and large, simple trials using non-traditional operational methods and processes.

Optimize the Potential of Your FDA-Approved Drug

Post-marketing commitments. New indications. Market extensions. Safety information. Real-world observations. Enhanced formulary positions. Bioclinica can support all your post-approval research requirements.

Bioclinica's Post-Approval Research division specializes in post-approval studies. We develop and implement customized solutions for each drug, specifically structured for the needs of post-approval research. Our strategies result in increased patient participation and greater data collection to facilitate proactive decision-making and continuous improvement. Our approach delivers:

  • Study design that anticipates clinic and patient needs
  • Superior data access and analysis
  • Precise identification of outcomes earlier in the process
  • Improved operations
  • Better ROI

Optimize the Potential of Your FDA-Approved Drug

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support you.

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A Comprehensive, Non-Traditional Solution

A Comprehensive, Non-Traditional Solution

Our comprehensive, full-service solution includes post-approval services from program design and protocol development to regulatory submission.

Depending on your post-approval goals, we can help you:

  • Identify new indications
  • Plan market extensions
  • Accentuate your formulary position
  • Collect critical safety information
  • Gain visibility through publications

Proven Expertise

Your drug has been approved for the marketplace, but your work isn't finished.

Post-approval studies need to be carried out to obtain real-world data, assess your product's safety profile, and support your product's lifecycle. Such studies require an innovative mindset, a specialized infrastructure, unique processes, customized technology, and targeted expertise. Bioclinica's Post-Approval Research division delivers all that and more.

Our Post-Approval Research division is comprised of a dedicated team with experience in designing and executing post-approval research for observational studies, post-marketing commitments, post-approval safety studies, and large, simple trials.

Proven Expertise

Post-Approval Research division

With a dedicated Post-Approval Research division, you benefit from:

  • SOPs specifically developed for post-approval research
  • Enhanced patient engagement, compliance, and retention
  • An increase in data collection by 25-30% by proven methodologies
  • Insightful study design that anticipates physician and patient needs
  • Superior data access and analysis for deep insights
  • Greater efficiency, resulting in cost savings of 15-20%
  • Solutions that maximize your return on investment
  • An expert staff 100% focused on post-approval research
  • Consultations and customized study design to optimize outcomes
  • Proven post-approval methodology and validated processes
  • Fully-integrated and flexible technologies created for post-approval studies

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support you.

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Integrated Technology

Post-marketing research is evolving rapidly and becoming increasingly complex. Unfortunately, pre-marketing Randomized Controlled Trial (RCT) technology is often applied in the post-marketing arena. This is a mistake, as it can decrease overall study efficiencies and increase study costs. Bioclinica's Post-Approval Research division utilizes post-approval-specific technology to maximize study efficiencies and costs, and optimize study outcomes.

Increase Efficiencies to Decrease Costs

Post-approval research varies from large, simple post-approval studies to large, complex safety surveillance studies. Bioclinica's post-approval technology is able to accommodate all types of study designs. Armed with this flexibility and scalability, you can alleviate unnecessary steps associated with pre-market RCT technology and databases, decreasing overall study costs by 10-15%.

Leverage Real-Time Data for Deeper Insights

Integrated Technology

Our integrated technology infrastructure is specifically designed to support post-approval research. Through this flexible, scalable, and customizable system, you can:

  • Access unique datasets and analytics, including real-time study metrics, to achieve greater clarity into your study
  • Obtain project metrics and quality/performance indicators
  • Integrate datasets from multiple datasets, including eCRF, Patient Reported Outcomes (PRO), safety data, third-party vendor data, and more for deeper insights
  • View discrete datasets and access analytics across datasets in real-time to survey and monitor progress on a routine basis
  • Benefit from full transparency for all stakeholders around the globe
  • Implement the necessary strategies to meet protocol and regulatory requirements and protect your investments
  • Provide access to real-time metrics and reports to sponsors, physicians, patients, CROs, and vendors to increase accountability and engagement in the study

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support you.

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Coordinated Management

Post-approval studies are complex and composed of many moving parts. Without careful planning and administration, your study will experience costly delays and inefficiencies. Our global Program Coordinating Center staff is 100% dedicated and are experts in the details of conducting post-approval research successfully.

Exclusively Focused on Coordinating and Supporting Participating Sites

Our Program Coordinating Center is designed to assist research sites around the globe by decreasing administrative burden and providing excellent customer service throughout the course of your post-approval study. With the power of our Program Coordinating Center behind your post-approval study, you benefit from:

  • Validated SOPs developed expressly for post-approval studies
  • Staff located globally to ensure real-time support in local languages
  • Execution of site management strategies tailored to meet the needs of physicians, from seasoned clinical research sites to research-naïve physicians
  • Remote monitoring that leverages post-approval-specific technology to enhance engagement and compliance with established protocols throughout the course of the study
  • Customized study reports that integrate multiple discrete data sets to help you analyze data and gain clarity

Bioclinica Program Coordinating Center Activities

Bioclinica Program Coordinating Center Activities

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support you.

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Patient Focus

Patient centricity is a critical component of post-approval studies, which is why we have established a Patient Outreach Center committed to facilitating and maintaining an ongoing relationship with study patients in their native languages. With our intensive focus on incorporating the patient voice and meeting patient needs, we will:

  • Engage patients through personalized phone, mail, and cutting-edge digital interactions
  • Improve patient compliance and minimize those lost to follow up
  • Increase data collection by 25-30% by proven methodologies compared to conventional PRO technologies
  • Maintain confidential patient data in compliance with country and state laws and regulations (HIPAA, FDA, EMA, etc.)

Bioclinica Patient Outreach Center Activities

Bioclinica Patient Outreach Center Activities

The World at Your Fingertips

Our Post-Approval Research division embodies substantial global trial experience and domain knowledge drawn from 100+ observational studies. But that is not all. Behind the Post-Approval Research division is the entire Bioclinica worldwide enterprise. When you partner with us to conduct your post-approval research, we can draw on additional sites, support, expertise, and resources as needed to optimize your post-approval study and ensure your success.

The World at Your Fingertips

Post-approval research. It’s all we do.

Contact us for more information or to speak with us about how we can support you.

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ADDITIONAL RESOURCES

Conducting post-approval research requires a unique mindset and specialized infrastructure. Do you have what it takes?

On Demand WEBINAR

Patient Centric Post-Approval Research: It's Time to Rethink How Post-Approval Studies Are Done

On Demand WEBINAR

Maximize the ROI of Your Post-Approval Research

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Post-Approval Research

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Patient Outreach Center

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Program Coordinating Center

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Post-Marketing Research

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Global Clinical Research

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LEARN MORE OR SPEAK WITH OUR EXPERTS

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Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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