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By: Sharon Powell on July 29th, 2019

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Locking Your Database The Pharm-Olam Way - 6 Tools Used To Achieve a Clean & Reliable Lock

Pharm-Olam Insights

data-lock

Your clinical trial has been running for years potentially and now it is time to achieve a database lock that is efficient, quality driven and on time.  A critical component to the overall success of any clinical trial is how Clinical Data Management (CDM) manages the trial during its conduct and how it closes it out to achieve database lock.

As you know, CDM is the process of collecting, analyzing, and integrating vast volumes of clinical data together to paint a picture of an investigative product or device safety and efficacy for our clients. CDM ensures all clinical data is handled not only in accordance with current global regulatory standards but meets the highest standards of Good Clinical Practice (GCP ICH). Having a solid CDM strategy ensures statistically sound data that enables stakeholders to develop sound, fact-based conclusions from subject data.

At Pharm-Olam, our years of experience in conducting all kinds of clinical trials underlines the importance of knowing the CDM process starts from the instant the first piece of data is received from our sites in the Electronic Data Capture (EDC) platform. Pharm-Olam has several tools at our disposal to clean and report on this data in an ongoing manner to help the full study team identify and mitigate any risk decisively:

  • Medidata Edge Central Monitoring
  • Rave EDC Reporting
  • SAS Programmed Exception Listings
  • Clean Subject Tracker (CST)
  • Patient Profiles
  • Rave Safety Gateway

In this post, we cover how Pharm-Olam leverages all of them to achieve a reliable and timely database lock, the Pharm-Olam way.  

 

1)  RAVE CENTRALIZED STATISTICAL ANALYTICS

Medidata’s Rave Centralized Statistical Analytics (Rave CSA) facilitates real-time review and global analysis of subject data across all regions of the world. Pharm-Olam uses this tool to transparently track site performance based on the timeliness and accuracy of a site’s data entry.

With Medidata Rave CSA, Pharm-Olam CDM develops site-centric, safety focused reports to get on-demand snapshots of the subject lab values and other assessments to our Pharmacovigilance and Medical Monitoring Teams. These real-time reports are easily accessible for all team members through a study portal showing site dashboards, tables, charts, or other visual graphics.

Rave CSA has machine learning algorithms to automatically detect and flag site entry errors for further review by CDM. These same algorithms identify data clusters, look for data patterns, and generate rules for the data cluster; any data not adhering to the rules are considered outliers and marked for evaluation. This trend analysis capability of Rave CSA significantly improves Pharm-Olam’s efficiency and accuracy well in advance of database lock and statistical analysis. 

dashboard-analytics-for-sponsors

Image is example of dashboards and analytics available to our teams and Sponsors.

 

2)  RAVE ELECTRONIC DATA CAPTURE (EDC)

Pharm-Olam CDM uses the industry leader in electronic data capture (EDC) technology, Medidata Rave EDC, to capture subject data from our investigative sites during a clinical trial. With Rave EDC, we obtain clinical assessment data as well as subject/caretaker clinical reported outcomes (diaries), integrate these data into comprehensive reports about the clinical trial. With data extraction tools such as ODM Adapter and SAS on Demand, Rave EDC enables CDM to develop sophisticated reports using J-Review and Business Objects.

These ad hoc reports provide insight into the overall state of any of our clinical trials as well as site-specific statistics. In addition to ad hoc reports, we use Rave EDC to schedule auto-generated reports for the convenience of our users. Several Rave EDC reports we develop are targeted to collate site and CRA performance metrics, such as whether there is a significant lag in site response or closure of queries issued by the system or manually generated by the study team.

One of the reasons we recommend using Rave EDC is because the full Medidata platform functionality enables the study team to make decisions, perhaps even revise the protocol parameters and the clinical database, based on real-time subject data and trending. Since we generate performance metrics, and assess subject enrollment/completion/screen failure rate/discontinuation throughout the life of a trial, we recognize study trends sooner.

Our team can proactively plan and make any necessary changes much faster than CROs using traditional methods of data collection and reporting after database lock. By the time the data is analyzed, and reports generated by the other CROs, it is too late to make any design modifications to a clinical trial. Pharm-Olam CDM and Statisticians leverage all the tools made available by Medidata in one platform working cohesively for our clinical teams.

 

3)  STATISTICAL ANALYSIS SYSTEM (SAS) PROGRAMMER

One of the ways that Pharm-Olam differs from other contract research organizations (CROs) is that we have a dedicated SAS programmer on our CDM team. Most CROs have their SAS programmers as part of the Biostatistics team, responsible for creating reports after database lock. Other CROs borrow a Biostatistics SAS programmer to help create SAS listings for their team to use for cleaning.

At Pharm-Olam, we recognize SAS programmers are essential to the success of a clinical trial, but not just towards database lock. At Pharm-Olam, our CDM SAS programmers create the link between subject data and reports presented to the study team and stakeholders. Our dedicated CDM SAS Programmer develops reports to speed up data cleaning and external data reconciliation in a way never done before.

At Pharm-Olam, we use our SAS Programmer to create exception listings and smart reconciliation reports detailing variations in laboratory data from external, third-party vendors. These exception listings are produced monthly throughout the duration of a clinical trial and speed up cleaning efforts and allow Pharm-Olam to perform an ongoing rolling lock of our subject data by CRF.

This efficiency enables the Pharm-Olam CDM to confidently meet aggressive database lock timelines within 10 days after the last data was received by Pharm-Olam. This is critical to achieving a reliable and clean database lock, the Pharm-Olam way. 

 

4)  CLEAN SUBJECT TRACKER

Next, Pharm-Olam also recognizes the need for our clients to know the database lock readiness status of their subjects in real-time, so Pharm-Olam CDM developed a Clean Subject Tracker (CST) which combines many layers of cross-functional data review and EDC performance metrics into a visual representation of the study status.

pharm-olam cst

Image is an example of Pharm-Olam CST in Excel format. 

Using our Clean Subject Tracker, CDM sees which subjects are considered “CLEAN” and which are deemed “DIRTY”, and teams can be mobilized to attack the areas requiring immediate cleaning attention. The identification of clean subjects signifies CDM should do one final review and freeze the CRF page(s) for the subject, thus eliminating site changes which would then fire another cycle of interim cleaning.

Typically, the output from our CST is in an Excel format for easy filtering, however, we also use Rave Centralized Statistical Analytics to enhance the reporting capabilities of our CST. Using Rave CSA, we can display our CST as tables or graphs, in addition to the standard Excel format.

Our weekly updated CST shows cumulative subject status for the following factors: vendor reconciliation, SAE reconciliation (if applicable), medical coding, Medical Monitor patient profile review, manual listing CDM review, open queries, SDV and CRF freeze status. By utilizing a CST tool and performing a rolling lock on patient data, we are able to offer our sponsors interim/periodic data cuts that are far cleaner than traditionally found in the industry.  

 

5)  PATIENT PROFILES

Rave CSA Patient Profiles can be used as a part of RBM, or as a standalone report from Medidata. Patient Profiles provide granular subject details such as drug dosing and how a subject responded to the drug dosage administered over time.

Patient Profiles provide real-time access to all the relevant subject data in an easy to visualize graphical format. In addition to our project sponsors, the Medical Monitors review the Patient Profiles monthly to assess the physical well-being of the subjects participating.

Furthermore, the format of the Patient Profiles is beneficial to our Safety Monitoring Committees and DSMBs for the studies. Data is used to inform dose escalation decisions, clinical study efficacy as well as a potential decision to pause enrollment due to safety concerns. Patient Profiles are essential in early phase clinical trials because Safety is the major determining factor of whether a clinical study should progress or be discontinued.

 patient-profile

Image is an example of Patient Profiles which are generated by Rave CSA.

 

6)  RAVE SAFETY GATEWAY

Last but not least, our Sponsors benefit from the use of Medidata’s Rave Safety Gateway. The ability to quickly and effectively report Serious Adverse Events (SAEs) is essential in clinical trials.

If a serious subject event occurs during a clinical trial, it is critical to notify the project Sponsor as well as other relevant parties such as Safety Committees, IRBs, Regulatory Authorities, etc., so appropriate medical interventions can be initiated in a timely manner.

At Pharm-Olam, we use Rave Safety Gateway to facilitate the collection of required documentation in one repository (Rave EDC).

When Medidata Safety Gateway is implemented for a study, the clinical database is structurally mapped to our Pharmacovigilance ARISg LifeSphere database. Rave Safety Gateway automatically transfers adverse events reported as ‘Serious’ by the site seamlessly to the Safety Database.

Why does Pharm-Olam strongly recommend using Medidata Safety Gateway?

  • No SAE Report Form is required, which lessens site burden to fill out a manual form, fax, and file the document;
  • No manual re-entry is needed into the Pharmacovigilance Safety Database;
  • No tedious monthly manual SAE reconciliation workflow;
  • No email threads to manage because PVG and Medical Monitors issue any questions regarding the SAE to the site via query management within EDC

 rave-safety-gateway

Easy, efficient management of subject data with the focus on subject safety.

The Rave EDC data easily integrates with other clinical study data collected from other sources or other tools. Comprehensive reports are generated in ARISg for notifying Medical Monitors, Sponsors, and any other authorities as required. Our use of Rave Safety Gateway eliminates human error in reporting and ensures important data is not duplicated in multiple databases.

 

IN CONCLUSION: 

When you spend millions of dollars running a clinical trial and it takes years to reach the end, you want to ensure that someone is always keeping an eye on the data, constantly cleaning it and effectively moving towards a timely and reliable database lock.

At Pharm-Olam, we know how important it is to achieve database lock and the tools and processes we utilize provide substantial benefits to our Sponsors. In business since 1994, we have helped hundreds of small and emerging biotechs as well as large-scale pharmaceutical companies achieve database lock and successfully conclude their clinical trials.

For more information about our clinical data management strategies and services, contact us today.