FAQ

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PSI FAQs: How does PSI use Robotic Process Automation (RPA) to support sponsors’ clinical trials?

Recent years have spurred the clinical trial industry to embrace innovative new solutions and technologies as a way to streamline processes and continue bringing trials to patients. However, the digital transformation started long before then. PSI CRO has consistently been a leader in applying sophisticated digital solutions to pivotal phase 2 and 3 clinical trials to optimize study modeling, budgeting, and operationalization, including developing our proprietary cloud-based suite of clinical trial planning tools, INTELIA™.

This forward-thinking approach also led to PSI’s early adoption of Robotic Process Automation (RPA) as a digital solution to standardize high-volume tasks and conduct them efficiently in an error-free manner. “While doing so, it builds quality control and compliance into the processes, cutting costs by 35 to 70%,” explained Doug Shannon, RPA Technology Lead at PSI CRO, in an interview with Labiotech.

PSI uses RPA to reduce processing time, human error rate, and the amount of routine work in several areas. For instance, automating the querying of abnormal laboratory values in EDC increased on time query processing by 100%. Other functions where RPA can support clinical trials include tasks that are heavy in documentation management, such as finance and accounting, supply chain, inventory management, and back-office processes like human resources and information technology services.

RPA offers several benefits for you as a sponsor, including:

  • Freeing up PSI team members’ time to focus on your trial’s most critical tasks
  • Capturing a sequential record of each step in every process, streamlining regulatory and drug safety data, and easing the burden of regulatory submissions preparation
  • Supporting PSI’s therapeutic area subject matter experts as part of a cross-functional approach to clinical data collection, analysis, and management

To learn more about how PSI incorporates RPA and other industry-leading technologies into our global CRO services, contact us today.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of 300 global radiopharmaceutical sites. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How does PSI use Robotic Process Automation (RPA) to support sponsors’ clinical trials? Read More »

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PSI FAQs: How do PSI CRAs support clinical site relationships?

At PSI, your last patient in is our first priority. Keeping this goal in mind is only possible with dedicated Clinical Research Associates (CRAs) that support your trial from end to end. This stability not only streamlines communication and transparency with your team but also with the sites who are critical to the success of your trial.

Each site on your study will have a single point of contact with one of our highly qualified CRAs, who serves as a site manager. This CRA’s responsibilities include:

• Ensuring sites are up to date and have all the essential documents
• Maintaining a deep working knowledge of the latest protocol version
• Confirming standards of care and investigator interest
• Ensuring a streamlined process of reporting
• Liaising with investigators and clinical research personnel
• Responding to site questions and providing regular remote follow-up in between visits

With experience working with 4,000 sites worldwide, we recognize that building relationships with investigators and site teams takes time. To ensure the success of each site relationship, our CRAs receive extensive project-specific and soft skills training. This difference between managing site relationships and simply monitoring sites can have a direct impact on the success of your current trial as well as a site’s willingness to work with a sponsor or CRO again in the future.

At PSI, we recognize that every patient counts. That’s why our CRAs go the extra mile to ensure our sites receive the support they need so that your study enrolls on time. Contact us today to learn more.

“I would like to thank you from the bottom of my heart for working so diligently for this patient. I know it was a lot of hard work by everyone but if you could have seen the patient’s face when I told her our site was activated it was worth it.”

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

A sponsor of a pivotal Phase 3 prostate cancer study investigating a radiopharm product approached PSI for support based on our experience and established network of 300 global radiopharmaceutical sites. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How do PSI CRAs support clinical site relationships? Read More »

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PSI FAQs: How does PSI reduce CRA staff turnover on your project?

Project team turnover can have a severe impact on your study’s timelines, leading to delays in everything from patient recruitment and site activation to data collection and study management. Clinical Research Associate (CRA) turnover rates in particular have climbed in recent years due to the COVID-19 pandemic and shifting economies, being reported as high as 30% in the US.

Despite this, PSI’s turnover has remained historically low with a company-wide staff turnover rate of only 14%. This kind of employee retention doesn’t just happen – it’s part of our commitment to stability for our biotech partners over the past 25 years.

While PSI offers competitive benefits and opportunities for employee recognition, we also support our CRAs in a number of other ways. We launched a CRA Academy to provide to help our team members develop therapeutic expertise as well as soft skills to manage key relationships with sites.

PSI also ensures that your study is effectively resourced by CRAs with manageable workloads by being selective about the projects take on. We are a specialized global CRO committed to pivotal Phase 2 and 3 clinical trials in select therapeutic areas, including oncology, hematology, gastroenterology, multiple sclerosis, and many rare diseases. This allows a more focused approach to resourcing, including providing additional study-specific training for CRAs on all new projects.

To learn more about how PSI ensures stability on your pivotal trial, contact us today.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Case Study

PSI managed to demonstrate swift feasibility and start-up ahead of schedule, leveraging site relationships, and fostering team consistency and stability. 

Global Reach

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases rely on PSI’s guidance and experience. 

The PSI Advantage

For the sixth year in a row, PSI CRO has been named a CRO Leadership Award winner in the categories of Expertise, Quality, and Reliability in the Overall (combined Big and Small pharma) respondent group. The CRO Leadership Awards are presented by Life Sciences Leader and Clinical Leader based on research conducted by ISR Reports. The awards recognize CROs that are voted by sponsors to meet or exceed expectations.

PSI FAQs: How does PSI reduce CRA staff turnover on your project? Read More »