Clinical Data Management
For over 20 years Linical has been providing Clinical Data Management services in a wide range of study designs and methods. We provide services from the design of the Case Report Form, database build, testing and validation, data entry, coding and Serious Adverse Event (SAE) management, to delivery of complete and accurate data in a customized output format.
Linical Corporate Clinical Data Management team offers tailored concepts across all key therapeutic areas with particular expertise not only in pivotal Phase II/III trials, but also for late-phase approaches. We combine experience with technology and therapeutic expertise to ensure actionable outcomes and highest quality and process acceptance in terms of the data we deliver.
As a customer-focused operation, we feature a robust service portfolio and deliver the highest quality results on every project. That’s why we have embedded quality checkpoints into our processes from beginning to end. Full GCDMP implementation of the Society for Clinical Data Management (SCDM). We are an industry partner of SCDM and Oracle® silver partner.
- Project management
- Protocol review
- Data management plan
- CRF designing, annotation, completion guidelines
- Database design, build and test
- Edit check programming and testing
- Data entry (single and double data entry)
- Data validation and Query management
- Data Integration services for due diligence
- Reconciliation of external data
- Coding services made by physicians using industry standard dictionaries (MedDRA® and WHODrug®):
- Adverse event
- Medical history
- Flexible reporting solutions
- Database lock and audit
- Database release using sponsor format (SAS, CDISC (SDTM, define.xml), etc)
Technology at Work for You
Linical envision technology as a powerful engine for promoting processes improvement, cost reduction and streamlining timelines. We use a combination of proprietary applications and partnership with third-party providers to offer our clients technology solutions that meet our high quality standards and fit our clients’ needs.
Electronic Data Capture (EDC)
Linical has a global agreement with Oracle, a US market leader in EDC technology, for the Enterprise adoption of their EDC (InForm) Solution. All operational and build activities are conducted by our own experienced EDC personnel. This EDC implementation allow us to fully control the process, being able to deliver the eCRF within 8 weeks after final protocol. It also has a big impact in the cost of the studies.
Rave has the industry’s leading clinical software cloud and integrate all of your data on an intuitive platform that drives intelligent insights. Optimize the outcome of your Clinical Research with solutions that reduce risk, drive improved performance and result in more accurate Clinical Research results. Hundreds of life science organizations have used this platform, in over 9,000 trials in more than 130 countries. As a provider of cloud-based solutions for clinical research, Medidata complies with regulatory expectations for software developers and service providers within the global regulatory environment.
Paper based studies
Oracle® ClintrialTM 6
If paper is the best fit for your study, Linical offers robust data collection using paper case report forms (CRFs). Linical implementation of the Oracle platform Clintrial 4.6, ensures fast and flexible setup and consistently clean data. 21 CFR Part 11 compliant, our clinical data management system (CDMS) provides for CRF inventory and tracking at the page level and independent double data entry.
Data Integration and Transformation
We have implemented an Extract, Transform and Load (ETL) tool specially validated to be used in the clinical research environment, which enables us to integrate data from various sources within a clinical trial or between different trials.
We have a deep expertise in the transformation of databases into industry standard SDTM.
A Web-based client portal suite that allows sponsors, vendors, study site staff and study team to exchange documents, discussions and messages in a secure environment 24/7
Linical enhances the capture and management of post-marketing study data ranging from pure observational to large critical PASS studies with advanced technology solutions.
Linical brings the same expertise in post-marketing studies as we do in every other phase of clinical development.
Data Standards is one of Linical’s strongest capabilities. The most widely accepted standards for clinical trial data are the CDISC (Clinical Data Interchange Standard Consortium) recommendations
Among others, CDISC standards bring the following benefits:
- To facilitate clinical data pooling, standard reporting, and data transfers with partners
- To comply with the Food and Drug administration (FDA) submission requirements
- To prepare clinical data into a data warehouse ready format to maximize its usability
Linical understands how to use the current CDISC standards CDASH (Clinical Data Acquisition Standards Harmonization) for data collection and SDTM (Study Data Tabulation Model) for data submissions, which is the format required by FDA for all data submissions.
Highly Qualified Personnel
All our staff have a university degree and we have established a certification program for all our Clinical Data Managers. At present, some of our senior Clinical Data managers are CCDM (Certified Clinical Data Managers) by the SCDM (Society for Clinical Data Management) organization.
We have broad experience running any type of study ranging from small phase I studies to studies with more than 1.2M pages.
We are proud to be a well-established team that continues to choose staying with Linical.
Our organizational structure and role definitions are optimized to reflect the most efficient workflows and processes:
- Data Project Managers.
- Clinical Data Managers.
- Clinical Programmers.
- Clinical Coders (Physicians).
- Data Entry Assistants.
We believe that there is not a single solution for all our clients; therefore we have developed several models of collaborations with our clients to satisfy their needs in terms of quality and cost.
Our collaboration models are:
- Project and task based sourcing. If you want to outsource the Clinical Data Management activities project by project, that is your model.
- Time-based sourcing. Our highly experienced personnel can work for you on a time-based sourcing. If you are looking for a clinical programmer with expertise in Oracle InForm, or you need a very experience Data Project Manager for managing your CDM trials, or are looking for a certified clinical data manager with experience in a given therapeutic area, that is your model.
- Functional Service Provider (FSP). Regardless of whether you are a big pharma or a small biotech, this model can work for you. We become an extension of your project team, being experts in Clinical Data Management. We provide an experienced and industry savvy team with the ability to provide support and knowledgeable recommendations regarding best practices in providing clinical data management support for clinical trials and programs.