EFFICIENT CLINICAL DATA MANAGEMENT IS THE KEY TO SUCCESSFUL TRIALS

Discover the Impact of Instant Collaboration and Real-Time Data

  • NCost-effective and streamlined
  • NStandardized metadata
  • NRapid CRF design and implementation
  • NIndustry leading database lock timelines
Efficient clinical data management is the key to successful trials

Discover the Impact of Instant Collaboration and Real-Time Data

  • NCost-effective and streamlined
  • NStandardized metadata
  • NRapid CRF design and implementation
  • NIndustry leading database lock timelines

Save time and enhance quality with our Clinical Data Management excellence

Our clinical data management services are designed to ensure the highest standard of data accuracy, compliance, and management throughout your trial’s lifecycle. We consistently surpass industry expectations by leveraging our innovative thinking, cutting-edge technology, and deep industry expertise. Our data collection, processing, storage, and analysis techniques are far beyond those of our competitors.

Explore how we perform faster, more accurately, and with features that were previously simply not possible.

Main areas of clinical data management

Unlock the potential of our service offerings

Our clinical data management process ideally begins at the protocol design phase of a clinical trial, where our expert clinical data managers (CDMs) analyze and provide input into the protocol. This guarantees a thorough alignment between the protocol and data capture instrument design. Employing a meticulous approach, we ensure that the participant journey is accurately represented in the final eCRF and data capture instruments, facilitating seamless navigation for site staff and maintaining logical trial flow. This attention to detail is paramount to ensuring that clinical trial data is reliable, accurate, complete and verifiable.

CRF design

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CRF design is crucial to effective and efficient study conduct as it has a direct impact on the accuracy and efficiency of data collection. Our expertise is in designing CRFs which accurately mirror a participant's clinical trial journey. This allows us to create a data collection flow which reduces errors, the number of queries, and even the amount of data entered for each participant.

EDC form design

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The CRF is only one of many EDC forms which our clinical data managers can design for your clinical trial. We can design or adapt your SAE report forms, protocol deviation logs, and any other data capture forms for implementation into our oomnia software. Our designs accurately replicate each SOP and associated study-specific plan to the last detail – including safety management, monitoring, and protocol deviation plans.

Electronic protocol deviation log implementation

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We implement your protocol deviation log as an electronic form exactly as per your SOPs and monitoring plan. All review, adjudication, approval, and sign-off processes are accurately represented, while dynamic behaviour and our industry-leading signing features guarantee compliance to SOPs and regulatory standards.

Automatic edit and data discrepancy checks

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;

We implement comprehensive automatic edit and data discrepancy checks, and dynamic behaviour and branching logic into our eCRFs and EDC documents. The validation rules, which auto-generate queries to clarify and correct data anomalies, dramatically increase real-time data quality and reduce the need for subsequent data cleaning activities.

Laboratory data management

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Wemedoo can automatically map direct data transfers from central laboratories via API or manual import. For local laboratories, we implement each local laboratory's reference ranges and units of measure into our oomnia software. This enables an instant automatic detection and entry of participant specific laboratory reference ranges. We also implement edit checks that are automatically applied to each participant.

Real-time integrated graphical reporting and analyses

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;

As our oomnia system has a unified database, our clinical data managers can create custom real-time integrated graphical reports, or data extracts for you. If you have an unmet data reporting or analysis need, we can almost certainly do the impossible.

eCRF implementation

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Our CDM experts implement the CRF exactly as it was designed, including dynamic in-eCRF completion instruction, edit checks, cross question data discrepancy checks, and dynamic behaviour with automated data cleaning. Dynamic behaviour is used to accurately mimic the participant journey and is implemented into virtually every eCRF field, reducing data entry requirements by 25-75% and manual queries by 33-67%.

Electronic SAE report form implementation

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;

Our CDM experts implement auto-generating electronic SAE report forms exactly designed as per your SOPs. They include automatic mapping of data from a participant eCRF, and automatic generation of follow-up and final report forms. Our implementation significantly reduces errors, reconciliations, and saves expensive time spent by expert medical monitors.

eCRF and EDC form completion guidelines

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Our CDMs write clear and comprehensive trial-specific eCRF completion guidelines and guidelines for all other EDC documents required for your trial. In combination with our user-friendly software interface, this results in easy eCRF and EDC form completion, fewer queries, and a smooth participant journey.

Data review, validation, and cleaning

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Our CDMs work with you to generate a data validation plan that is cost effective and is tailored your specific trial needs. Our data review and validation processes take a risk-based approach where we identify critical data for primary, main secondary, and safety endpoints. Data review at well planned intervals means reduced time spend on data correction by monitors, sites, and clinical data managers.

Data integration and management

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Our software development team and clinical data managers can integrate and validate data transfers from most any external data source. These include CORE labs, wearables, EHRs, and much more.

Database lock and decommissioning

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After completion of the study, all our study conduct services result in a very clean database. Combined with our clear and concise database export and lock processes, we can perform database lock and study finalization that is 2-3 times faster than the competition, at a fraction of the price.

CRF design

:
;
CRF design is crucial to effective and efficient study conduct as it has a direct impact on the accuracy and efficiency of data collection. Our expertise is in designing CRFs which accurately mirror a participant's clinical trial journey. This allows us to create a data collection flow which reduces errors, the number of queries, and even the amount of data entered for each participant.

EDC form design

:
;

The CRF is only one of many EDC forms which our clinical data managers can design for your clinical trial. We can design or adapt your SAE report forms, protocol deviation logs, and any other data capture forms for implementation into our oomnia software. Our designs accurately replicate each SOP and associated study-specific plan to the last detail – including safety management, monitoring, and protocol deviation plans.

Electronic protocol deviation log implementation

:
;

We implement your protocol deviation log as an electronic form exactly as per your SOPs and monitoring plan. All review, adjudication, approval, and sign-off processes are accurately represented, while dynamic behaviour and our industry-leading signing features guarantee compliance to SOPs and regulatory standards.

eCRF implementation

:
;
Our CDM experts implement the CRF exactly as it was designed, including dynamic in-eCRF completion instruction, edit checks, cross question data discrepancy checks, and dynamic behaviour with automated data cleaning. Dynamic behaviour is used to accurately mimic the participant journey and is implemented into virtually every eCRF field, reducing data entry requirements by 25-75% and manual queries by 33-67%.

Electronic SAE report form implementation

:
;

Our CDM experts implement auto-generating electronic SAE report forms exactly designed as per your SOPs. They include automatic mapping of data from a participant eCRF, and automatic generation of follow-up and final report forms. Our implementation significantly reduces errors, reconciliations, and saves expensive time spent by expert medical monitors.

eCRF and EDC form completion guidelines

:
;

Our CDMs write clear and comprehensive trial-specific eCRF completion guidelines and guidelines for all other EDC documents required for your trial. In combination with our user-friendly software interface, this results in easy eCRF and EDC form completion, fewer queries, and a smooth participant journey.

Automatic edit and data discrepancy checks

:
;

We implement comprehensive automatic edit and data discrepancy checks, and dynamic behaviour and branching logic into our eCRFs and EDC documents. The validation rules, which auto-generate queries to clarify and correct data anomalies, dramatically increase real-time data quality and reduce the need for subsequent data cleaning activities.

Laboratory data management

:
;
Wemedoo can automatically map direct data transfers from central laboratories via API or manual import. For local laboratories, we implement each local laboratory's reference ranges and units of measure into our oomnia software. This enables an instant automatic detection and entry of participant specific laboratory reference ranges. We also implement edit checks that are automatically applied to each participant.

Real-time integrated graphical reporting and analyses

:
;
As our oomnia system has a unified database, our clinical data managers can create custom real-time integrated graphical reports, or data extracts for you. If you have an unmet data reporting or analysis need, we can almost certainly do the impossible.

Data review, validation, and cleaning

:
;

Our CDMs work with you to generate a data validation plan that is cost effective and is tailored your specific trial needs. Our data review and validation processes take a risk-based approach where we identify critical data for primary, main secondary, and safety endpoints. Data review at well planned intervals means reduced time spend on data correction by monitors, sites, and clinical data managers.

Data integration and management

:
;
Our software development team and clinical data managers can integrate and validate data transfers from most any external data source. These include CORE labs, wearables, EHRs, and much more.

Database lock and decommissioning

:
;
After completion of the study, all our study conduct services result in a very clean database. Combined with our clear and concise database export and lock processes, we can perform database lock and study finalization that is 2-3 times faster than the competition, at a fraction of the price.

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Benefits of our service

Experience the impact of superior data management

Clinical data management services by Wemedoo bring a host of benefits to your clinical trials. We streamline, accelerate, and enhance the clinical research processes, ensure industry-leading data integrity and accuracy, while reducing costs and timelines. Our serivces are all vital for exceptional trial outcomes.

Eager to explore tailored services?

Discover how our clinical trial services can revolutionize your research. Take the first step towards unmatched trial efficiency and success today.

Frequently asked questions

Get the answers you need about our clinical data management service

What does clinical data management at Wemedoo entail?

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Our service includes comprehensive management of clinical trial data, from collection and validation to analysis, data monitoring and reporting. We ensure quality, accuracy, timeliness, and compliance with regulatory standards.

How does Wemedoo ensure data security in clinical trials?

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We implement robust security protocols, including encryption and access controls, to safeguard sensitive trial data against unauthorized access and breaches.

Can the data management system be customized to specific trial needs?

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Absolutely, we understand that not all trials can be accommodated in the same manner. We offer customizable data solutions tailored to meet the unique requirements of each clinical trial. We consult with you to come up with a tailored suite of services that match your needs.

What kind of data analysis and reporting capabilities does Wemedoo offer?

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Our services provide advanced clinical data analytics tools and real-time reporting features, enabling insightful data interpretation, reducing risk, increasing quality and decision-making. All tools ensure quality, accuracy, and compliance with regulatory standards and guidelines.

How does Wemedoo clinical data management service comply with regulatory requirements?

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Our team are experts in their respective fields and are well versed regarding global data standards and regulatory guidelines, ensuring comprehensive compliance throughout your trial's clinical data data management process. Our extensive quality control systems have been developed exactly for our services and SOPs. This means all our deliverables are of the highest quality and exceed all regulatory requirements.

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Learn more about how we can support your cinical trials.

Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond clinical data management, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes, saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.
Protocol Development
Risk-Based Monitoring and Source Data Review
eTMF Setup and Administration
Biostatistics and Statistical Programming
CDISC-Compliant Dataset Generation
Medical Writing and Documentation
Our certifications
We are ISO 9001 and ISO 27001 certified. Our commitment to robust information security and superior quality management is at the core of our innovative solutions, ensuring reliable and efficient trial management for our clients.

What our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."
Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Considering unified clinical trial software?

Experience oomnia, our all-in-one clinical trial software which unifies tools, such as EDC, RTSM, eTMF, ePRO, eCOA, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.