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.

acdm Awards Finalist
acdm awards 2024 finalist for “Team Excellence in the Management of Clinical Data”.

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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A well-structured CRF is essential for accurate and efficient data collection. Our designs mirror the participant’s journey, reducing errors, minimizing queries, and optimizing data entry workflows to improve study conduct.

EDC form design

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Beyond CRFs, we create and adapt EDC forms such as SAE reports and protocol deviation logs. Every form is designed to align with SOPs, study-specific plans, and regulatory requirements, ensuring seamless integration with oomnia.

Electronic protocol deviation log implementation

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We digitize protocol deviation logs according to SOPs and monitoring plans, automating review, adjudication, and approvals. Dynamic behavior and industry-leading compliance features ensure regulatory alignment.

Automatic edit and data discrepancy checks

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Built-in validation rules, dynamic behavior, and branching logic detect and resolve data discrepancies in real-time, increasing accuracy while reducing post-entry data cleaning.

Laboratory data management

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We streamline lab data integration by mapping automated transfers from central laboratories or manual imports. Local lab reference ranges and unit conversions are embedded into oomnia, ensuring precise, real-time detection of patient-specific lab values.

Real-time integrated graphical reporting and analyses

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As our oomnia system has a unified database, we generate real-time graphical reports and custom data extracts, giving study teams immediate insights and enabling informed, data-driven decisions.

eCRF implementation

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Our eCRFs incorporate dynamic behavior, automated data cleaning, and validation checks, reducing manual queries by up to 67% and optimizing data entry processes for site staff.

Electronic SAE report form implementation

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We implement auto-generating SAE report forms with direct eCRF integration. Automated mapping and real-time follow-up generation reduce errors and streamline safety reporting, saving valuable monitoring time.

eCRF and EDC form completion guidelines

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To ensure smooth data entry, our team provides clear, trial-specific eCRF and EDC completion guidelines. Combined with a user-friendly interface, this simplifies form completion, reduces errors, and enhances workflow efficiency.

Data review, validation, and cleaning

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Our risk-based data validation plans prioritize critical study endpoints, reducing the need for corrections while ensuring clean and accurate data for regulatory submissions.

Data integration and management

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We support seamless data integration from external sources such as CORE labs, wearables, and EHRs. Our automated validation processes ensure consistency and reliability across all integrated datasets.

Database lock and decommissioning

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After study completion, we perform database lock and finalization 2-3 times faster than industry standards using optimized export and lock processes, ensuring a validated, audit-ready database.

CRF design

:
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A well-structured CRF is essential for accurate and efficient data collection. Our designs mirror the participant’s journey, reducing errors, minimizing queries, and optimizing data entry workflows to improve study conduct.

EDC form design

:
;
Beyond CRFs, we create and adapt EDC forms such as SAE reports and protocol deviation logs. Every form is designed to align with SOPs, study-specific plans, and regulatory requirements, ensuring seamless integration with oomnia.

Electronic protocol deviation log implementation

:
;
We digitize protocol deviation logs according to SOPs and monitoring plans, automating review, adjudication, and approvals. Dynamic behavior and industry-leading compliance features ensure regulatory alignment.

eCRF implementation

:
;
Our eCRFs incorporate dynamic behavior, automated data cleaning, and validation checks, reducing manual queries by up to 67% and optimizing data entry processes for site staff.

Electronic SAE report form implementation

:
;
We implement auto-generating SAE report forms with direct eCRF integration. Automated mapping and real-time follow-up generation reduce errors and streamline safety reporting, saving valuable monitoring time.

eCRF and EDC form completion guidelines

:
;
To ensure smooth data entry, our team provides clear, trial-specific eCRF and EDC completion guidelines. Combined with a user-friendly interface, this simplifies form completion, reduces errors, and enhances workflow efficiency.

Automatic edit and data discrepancy checks

:
;
Built-in validation rules, dynamic behavior, and branching logic detect and resolve data discrepancies in real-time, increasing accuracy while reducing post-entry data cleaning.

Laboratory data management

:
;
We streamline lab data integration by mapping automated transfers from central laboratories or manual imports. Local lab reference ranges and unit conversions are embedded into oomnia, ensuring precise, real-time detection of patient-specific lab values.

Real-time integrated graphical reporting and analyses

:
;

As our oomnia system has a unified database, we generate real-time graphical reports and custom data extracts, giving study teams immediate insights and enabling informed, data-driven decisions.

Data review, validation, and cleaning

:
;
Our risk-based data validation plans prioritize critical study endpoints, reducing the need for corrections while ensuring clean and accurate data for regulatory submissions.

Data integration and management

:
;
We support seamless data integration from external sources such as CORE labs, wearables, and EHRs. Our automated validation processes ensure consistency and reliability across all integrated datasets.

Database lock and decommissioning

:
;
After study completion, we perform database lock and finalization 2-3 times faster than industry standards using optimized export and lock processes, ensuring a validated, audit-ready database.

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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
oomnia – Meeting Industry Standards

Our unified clinical trial software is designed with compliance at its core, meeting critical industry standards. Our commitment to these regulations ensures that your clinical trials are not only efficient but also adhere to the highest levels of data integrity, privacy, and ethical conduct.

See 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, eSource, RTSM, eTMF, ePRO, eCOA, eConsent, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.