Data management

Services

Data management

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.
Introduction
We manage all aspects of your data—from study startup to submission—collaborate closely with clinical teams to ensure that the timelines and milestones of the trial are met.
Introduction
Clinical Data Management

Bioforum’s Clinical Data Management team is fully committed to providing high-quality and reliable services using the industry’s leading technology designed for quality data capture.

We manage all aspects of your data—from study startup to submission—and collaborate closely with clinical teams, ensuring they meet the timelines and milestones of their trial.

As the Data Masters, we take a leading role in the professional arena in various data management committees such as: The Society for Clinical Data Management (SCDM) and the Association for Clinical Data Management (ACDM). This allows us to share our knowledge and experience and to be up to date with the most innovative approaches, updated guidelines and advanced platforms for efficient collection, standardization and reporting of data in clinical trials.

We strongly stand by the industry standards by complying with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC).

Bioforum’s Clinical Data Management Support Services:

  • eCRF design
  • Database configuration & build
  • Data validation checks programming
  • Clinical data management plan development
  • Clinical data review and query management
  • External data transfer and reconciliation
  • Adverse event, concomitant medication and medical history coding
  • SAE reconciliation between safety and clinical databases
  • Development of custom status reports
  • Database lock procedures

 

Introducing BioGRID

The most effective way to graphically represent data-driven insights 

Bioforum’s clinical research experts have developed an intuitive and easy-to-navigate analytics and visualization platform. BioGRID brings clinical trial data together in a clear, focused manner to drive smart decision-making processes.

Visualizing Clinical Trial Data

A powerful tool to make data accessible and simplify complexity

Presenting the huge amounts of data clinical studies generate can be challenging. How can you show as much information as possible in an easily understandable manner?

Managing the Soaring Volume and Diversity of Clinical Trial Data

The era of hybrid and decentralized clinical trials is here. New and different data sources –  from wearables and apps to imaging platforms and central labs – must be considered when curating and presenting research information to stakeholders in a comprehensive way. 

This volume and variety of clinical trial data will only continue to expand rapidly, far beyond what a simple spreadsheet can manage.

A Solution that Powers Informed-Decision Making

 

To keep clinical trials on schedule and within budget, sponsors must make informed decisions in a timely manner. Study teams must review and analyze clinical data to mitigate risk and monitor safety and effectiveness. 

BioGRID allows study teams within sponsor and CRO organizations to bring together all clinical trial data sources in an actionable report. Via an interactive dashboard, research stakeholders can view the information that matters, filtering, sorting and cross referencing data to get the information needed in real time.

BioGRID sorts all the data, freeing study teams from the tedious, manual work involved in copying and pasting from multiple spreadsheets or logging into several databases to view data. BioGrid also allows study teams to quickly compile all the necessary information and present it to other stakeholders in an easily digestible format.

Sponsor and CRO teams can use BioGRID to improve outlier detection, screening and enrollment tracking and safety review. BioGRID also helps highlight underlying trends, such as potential or emerging risks.

Let Your Data Do the Talking

A fully customizable tool to drive efficiency, optimizing trial monitoring and management 

  • Compile as much data as you need
  • Drill down as far down as you like
  • Configure any graphic you prefer
  • Add the measurements and calculations you require
  • Work within the timelines you design 
Electronic Data Capture

Bioforum partners with leading industry technology vendors worldwide to meet the professional needs of our clients. From small-scale studies to large clinical programs, we offer versatile technology solutions to accelerate clinical development.

Our vast experience with the diverse components of the development lifecycle includes EDC software, IWRS solutions, ePRO applications and more.

Furthermore, we have developed an agile and unique process for database build that ensures the best design for each study, based on input provided from medical, technical and data management perspectives. Our medical advisors are pivotal in any data-capturing tool design and streamline the translation of protocol and desired analysis points into the eCRF. They also provide the clinical component of the delivery to ensure that safety, efficacy and quality aspects are properly covered. In addition, clinical trial expertise is applied during the build process, considering the best data-related principles and standards as well as end users’ utilization of the system. And finally, our technical team is highly trained and skilled to ensure optimization in data capture even in complex designs.

 

Scientific Credible Data

Bioforum’s data review strategy is based on a multi-functional and adaptive design to meet customer needs and to ensure the delivery of quality, accurate and scientifically credible data.

A multi-functional approach not only guarantees data integrity, but collaboration amongst the different Bioforum stakeholders (Clinical Project Manager, Clinical Data Coder, DM Programmer, Medical Advisor, Validation Lead and a Data Scientist) ensures that the data meet protocol, GCP, regulatory and therapeutic requirements.

 

Data Accuracy

Our aim as Data Masters is to drive innovation within Data Sciences, to adapt and adopt to change and constantly improve our approach to data review.

Bioforum is a true ambassador for utilizing new and improved review tools/processes. We promote a targeted data review approach, which is not only in line with the global evolution of data management in clinical research, but also greatly contributes to the delivery of accurate data. Key components in our review approach are:

  • Smart and pro-active query management
  • Holistic data review
  • Smart programmed data listings
  • Data & metric visualizations

 

Data Quality

Data quality is focused on more than just accuracy. We integrate many more quality dimensions to deliver data that are FIT FOR PURPOSE.

  • Completeness
  • Consistency
  • Relevance
  • Conformity
  • Trustworthiness
  • Integrity

Bioforum sets great store on data quality and utilizes robust and effective quality controls to guarantee fit-for-purpose delivery.

  • Standard operating procedures
  • Monitoring of data trends and metrics
  • Review guidance and specifications
  • Data review quality checks

We believe that higher data quality leads to better clinical decision-making that ensures patient safety.

Medical Review

Bioforum’s Medical Advisors have vast experience in drug development, medical device and drug-device consultation. The team works closely with Clinical Data Management, ClinOps, Medical Writing and PV, and also provides a unique set of services of medical input to CRF design, data review specification, data cleaning and medical coding quality control.

 

Medical Advisors

Bioforum’s Medical Advisors work alongside Data Management to provide medical input on each step of the data management deliveries, together as one team, creating a unique combination of expertise that makes a difference by adding value to the quality for which Bioforum is already known:

  • CRF design and UAT
  • Data review specifications
  • Data cleaning
  • Scientific reviews
  • Medical coding quality control
  • Preparing data for interim analysis and database lock
Our Expertise
Innovative Approach
Collaborative database design combining medical & technical expertise
Risk Management
Integrated risk-based approach for effective project delivery
Clinical Data Management Systems

Meet our team

Manage all of your data with our professional, experienced and efficient Data Management team.

Irina Sher
VP, Data Management
Holds a M.Sc. in Epidemiology from Ben-Gurion University of the Negev, Beer Sheva, Israel. She has been a part of the Bioforum team for 7 years and is responsible for leading and overseeing all data management personnel, as well as directing and guiding the data management activities for the company. Irina develops and implements strategies and policies for data management that maximizes the quality, reliability, and efficiency of Bioforum’s services. She also ensures that our client’s requirements are always met to their standards and the industry performs its best practices.
Tanya Du Plessis
Chief Data Strategist and Solutions Officer
As a certified clinical data manager, Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State, as well as her project management professional certification. She has vast industry experience with over 14 years with IQVIA (legacy Quintiles). As manager of various data management operation teams, Tanya has actively lead strategies for customized data delivery solutions focusing on timely quality data. She has driven numerous innovation teams, and her dedication to optimal customer service/delivery is visible through her long standing relationships.
Kira Yasinovsky
Senior Director, Operational Excellence
Kira has over 14 years of experience in clinical trials industry and more than 10 years of Data Management expertise including study planning and study conduct activities, especially database planning and configuration in various EDC systems. With this wide experience and after having riles with increasing responsibility, Kira is leading a group of professionals responsible for quality and efficiency improvement and taking the department towards excellence. Kira holds a B.Sc. in Neuro Sciences from Bar Ilan University and M.Sc in Medical Sciences from Tel Aviv University.
Adri Erasmus
Director, Project Management
With strong program and project management skill’s herself, Adri drives a professional and dedicated project management team. Her passion for project management and customer delivery ensures high quality, and focused project management delivery. Working closely with the data sciences team and colleagues across all departments, her exceptional leadership skills and well-established experience are a big asset to the team. Her drive for innovation and her passion for exceptional customer service ensures only the best service from her team.
Nadia Nahmany
Director, Process Optimization
Nadia began her career path as a registered nurse, later following her passion for clinical research and completing a Master’s degree in Medical Science while working as a study coordinator and research assistant in a cardiology department. After joining the Bioforum family in 2016 she has held various positions throughout the years, growing with the company and learning the tricks of the trade from the inside. Working closely with colleagues across all teams Nadia strives to enhance the performance and the effectiveness of the DM Department. With strong technical and clinical skills along with her passion for quality and innovation, Nadia drives initiatives to optimise the working processes of the DM department and achieve the best results for our clients. In addition to her DM professional role, after moving to Australia in 2017 Nadia has been taking an active part in Business Development for the APAC region.
Johan Vermeulen
Director, Clinical Data Sciences
Johan Vermeulen is Director, Clinical Data Sciences with a demonstrated history of working in the pharmaceutical industry. He is working alongside the Data Management (DM) management team to ensure customer satisfaction and exceptional delivery. Johan specializes in Project Management/Data Management processes and strategies and is responsible for leading the Global Clinical Data Sciences team (Data Sciences, Clinical Data Coding & Validation) to success through innovations and progressive DM processes. With 8 years’ experience in the CRO industry, Johan is a powerful force in the workplace and uses his positive attitude, transparency and passion for people to encourage others to work hard , to accept every challenge as an opportunity, to become their best selves. Johan is a driven individual that strives to improve, to grow and to become the best husband, father, employee and own self he can be.
Francois Van Vuuren
Associate Director, Data Management Programming
I joined Bioforum on the 1st of February 2021 with 17 years industry experience, specializing in SAS programming and visualized analytics. My main focus is on planning, directing or coordinating activities in fields such as programming, systems analysis, electronic data processing, transfers and visualizations within the data management department.
Lusiane Lea Belaus
Global Medical Director, Clinical Data Management and Specialty Services
Lusiane Lea Belaus first joined Bioforum in 2009, following her medical studies in South America and holds a BioMed MBA from the College of Management Academic Studies from Israel. She is currently pursuing a Clinical Research PhD at the Victoria University of Wellington in New Zealand. Lu’s background includes big pharma (Teva Pharmaceuticals) biotech start ups, academia (University of Auckland), clinical trials intelligence and scientific publications (Springer Nature). Lu has worked as a certified Clinical Data Manager, Head of Medical Data Review and Medical Coding, Medical Monitor and Clinical Trial Manager and Operations Lead for early and late phase multi-centric studies with a strong focus on Neurology, Psychiatry and Oncology Therapeutic areas. Currently, within the Clinical Data Management, Lu leads the Medical Advisors team who ensures that the DM deliveries meet the medical requirements and clinical standards. In addition to Clinical Data Management, Lu is heading the growing Medical Monitoring and Clinical Trials Management specialty services.
Irina Sher
VP, Data Management
Holds a M.Sc. in Epidemiology from Ben-Gurion University of the Negev, Beer Sheva, Israel. She has been a part of the Bioforum team for 7 years and is responsible for leading and overseeing all data management personnel, as well as directing and guiding the data management activities for the company. Irina develops and implements strategies and policies for data management that maximizes the quality, reliability, and efficiency of Bioforum’s services. She also ensures that our client’s requirements are always met to their standards and the industry performs its best practices.
Tanya Du Plessis
Chief Data Strategist and Solutions Officer
As a certified clinical data manager, Tanya holds a M.Med.Sc in Hematology and Cell Biology from University of the Free State, as well as her project management professional certification. She has vast industry experience with over 14 years with IQVIA (legacy Quintiles). As manager of various data management operation teams, Tanya has actively lead strategies for customized data delivery solutions focusing on timely quality data. She has driven numerous innovation teams, and her dedication to optimal customer service/delivery is visible through her long standing relationships.
Kira Yasinovsky
Senior Director, Operational Excellence
Kira has over 14 years of experience in clinical trials industry and more than 10 years of Data Management expertise including study planning and study conduct activities, especially database planning and configuration in various EDC systems. With this wide experience and after having riles with increasing responsibility, Kira is leading a group of professionals responsible for quality and efficiency improvement and taking the department towards excellence. Kira holds a B.Sc. in Neuro Sciences from Bar Ilan University and M.Sc in Medical Sciences from Tel Aviv University.
Adri Erasmus
Director, Project Management
With strong program and project management skill’s herself, Adri drives a professional and dedicated project management team. Her passion for project management and customer delivery ensures high quality, and focused project management delivery. Working closely with the data sciences team and colleagues across all departments, her exceptional leadership skills and well-established experience are a big asset to the team. Her drive for innovation and her passion for exceptional customer service ensures only the best service from her team.
Nadia Nahmany
Director, Process Optimization
Nadia began her career path as a registered nurse, later following her passion for clinical research and completing a Master’s degree in Medical Science while working as a study coordinator and research assistant in a cardiology department. After joining the Bioforum family in 2016 she has held various positions throughout the years, growing with the company and learning the tricks of the trade from the inside. Working closely with colleagues across all teams Nadia strives to enhance the performance and the effectiveness of the DM Department. With strong technical and clinical skills along with her passion for quality and innovation, Nadia drives initiatives to optimise the working processes of the DM department and achieve the best results for our clients. In addition to her DM professional role, after moving to Australia in 2017 Nadia has been taking an active part in Business Development for the APAC region.
Johan Vermeulen
Director, Clinical Data Sciences
Johan Vermeulen is Director, Clinical Data Sciences with a demonstrated history of working in the pharmaceutical industry. He is working alongside the Data Management (DM) management team to ensure customer satisfaction and exceptional delivery. Johan specializes in Project Management/Data Management processes and strategies and is responsible for leading the Global Clinical Data Sciences team (Data Sciences, Clinical Data Coding & Validation) to success through innovations and progressive DM processes. With 8 years’ experience in the CRO industry, Johan is a powerful force in the workplace and uses his positive attitude, transparency and passion for people to encourage others to work hard , to accept every challenge as an opportunity, to become their best selves. Johan is a driven individual that strives to improve, to grow and to become the best husband, father, employee and own self he can be.
Francois Van Vuuren
Associate Director, Data Management Programming
I joined Bioforum on the 1st of February 2021 with 17 years industry experience, specializing in SAS programming and visualized analytics. My main focus is on planning, directing or coordinating activities in fields such as programming, systems analysis, electronic data processing, transfers and visualizations within the data management department.
Lusiane Lea Belaus
Global Medical Director, Clinical Data Management and Specialty Services
Lusiane Lea Belaus first joined Bioforum in 2009, following her medical studies in South America and holds a BioMed MBA from the College of Management Academic Studies from Israel. She is currently pursuing a Clinical Research PhD at the Victoria University of Wellington in New Zealand. Lu’s background includes big pharma (Teva Pharmaceuticals) biotech start ups, academia (University of Auckland), clinical trials intelligence and scientific publications (Springer Nature). Lu has worked as a certified Clinical Data Manager, Head of Medical Data Review and Medical Coding, Medical Monitor and Clinical Trial Manager and Operations Lead for early and late phase multi-centric studies with a strong focus on Neurology, Psychiatry and Oncology Therapeutic areas. Currently, within the Clinical Data Management, Lu leads the Medical Advisors team who ensures that the DM deliveries meet the medical requirements and clinical standards. In addition to Clinical Data Management, Lu is heading the growing Medical Monitoring and Clinical Trials Management specialty services.
Frequently Asked Questions
Are there any recent regulatory updates concerning data managment practice?
Although ICH Q9 already directed our focus to risk-based quality management of our trials, the release of ICH E8 on Oct 21st, 2021 ushered in a new era in how we should be thinking about our clinical trial data. These regulations clearly describe how the regulatory authorities are expecting “Critical to Quality Factors” to be documented and managed. They emphasize the fact that this should be done at study start, and that study data have quality factors that should be considered at study design and proactively managed during the trial. Additionally, the internationally recognized data standards are significant as they support data reliability. This is important since data reliability helps facilitate correct analysis and interpretation of results. Lastly, the regulators make it clear that data management is a critical/key contributor to overall study data quality. It is also important that data management is part of the risk management and decision-making processes. As part of their role in the clincial study process, the data management team must identify the “critical to quality factors” that come from the way study data are collected, managed and reviewed. With new regulations having specific requirements, you can expect to be asked for evidence of all of the above at your next regulatory inspection.
How do I choose an EDC platform?
Choosing the right EDC platform starts by asking the right questions. It’s important to begin by asking which functionality is necessary. This may seem obvious, but this critical step often gets missed. It’s very easy to be lured in by the bells and whistles many systems offer, but do they address your company’s needs for specific studies? Identify these needs and then analyze and prioritize them. Doing so will help you narrow down and simplify the criteria on which to base your decision and how to potentially adjust your budget. The next subject to tackle is whether the EDC integrates with other systems in your technology portfolio and how the EDC vendor’s pricing fits in with your budget. Of course, even having the right questions lined up sometimes doesn’t help when talking to various vendors. With strong sales pitches and overwhelming technical explanations, it is easy to get lost in all the information…. Read the blog HERE to help you put together a robust plan to help you through the weeds in making this decision.
Is a full RBQM approach too “risky”?
From the various regulatory releases over the last 5 years, it is clear that authorities are supportive of taking risk-based approaches to clinical trial management. This applies to data management and provides a different approach to data cleaning than the traditional blanket cleaning (clean as much as possible as thoroughly as possible) as well. They are telling us through their recent releases that they are not expecting all data to be clean but are rather simply expecting “the absence of errors that matter”. This confirms that notion that not all data should be cleaned equally...but where is the line… Read our blog here to help guide you through this decision.