ClinTrialStat Clinical Data Services utilizes strict quality standards, operating procedures, and innovative Internet technology to deliver high quality clinical databases in the fastest possible time.

Our dedicated DM Project Teams work closely with Sponsors through all phases of database specification development, and strive to function as an extension of your global data management operations. We believe close communication and collaboration, particularly at the earliest definition stages, promotes firm and hands-on assurance that your protocol requirements are being met in ways that facilitate accurate, consistent, and complete clinical deployments.

Quality process controls are built into every step of our data management procedures. We know from first-hand experience that these are the principal drivers in delivering clean databases that reduce overall cycle times. Nonetheless, unless these quality methods are closely integrated with robust, enabling technologies, their full business impact and potential are not easily realized. Our unique blend of expert clinical knowledge, process engineering, and Internet-based solutions provides you with the reliable data services you need to efficiently lock your databases with optimal speed and quality.

Comprehensive Clinical Data Management Services

Data management consultation
Data management plans and validation conventions
Case report form design and production
CRF annotation and data transfer schema
CRF completion guidelines
Database design, construction, and qualification
CRF logging, tracking and thorough pre-entry review
CRF imaging and indexing
Double data entry and verification
Data field and cross-form edit checking
Central laboratory, imaging, and ECG feed integration
Secondary data review and quality assurance
Automated and manual query management
Preferred term encoding, such as MedDRA, WHOdrug
SAE reconciliation
Database freeze, lock and audit
Data validation meeting

With our flexible ClinTrialStat e-Clinical platform you have the capability to completely isolate and outsource the entire document tracking/data entry process from the rest of the clinical data management function. Your in-house data managers may handle the clinical review, query management, medical encoding, and database locking responsibilities. You hire us, or possibly an overseas resource, to handle the auxiliary functions all at a savings to you. The choice is yours.

When you choose ClinTrialStat Services as your CDM provider, you are selecting a project Team that will be extensively qualified and committed to your clinical program. Once the protocol and CRF are approved, Team members are thoroughly trained in the specifics of your experimental design, modes, and sites of therapeutic activity particular safety considerations, protocol objectives, and critical variables that are being collected. We are fully intent on instilling a firm sense of hands-on ownership, responsibility, and pride in delivering this important quality-assured database, on-time, on-target, and on-budget.

Query Management Options

Several modes of site communications are available through our e-Clinical platform in support of the corrections and clarifications query process:

A secure Internet interaction is the most efficient option that offers the quickest and most efficient response performance, minimized investigative site effort, and an automated audit trail.
Automated two-way fax best accommodates sites with limited web connectivity; response processing performance is enhanced by DCF indexing.
Two-way mail and fax-out/mail-in best suits minimally connected sites and situations where physical signatures are preferred or required.

Our powerful role-based security engine allows you to deploy any or all of these options for a particular clinical trial. Of course, there are varying manual data management processing requirements associated with each option, but you also have the ability to allocate a mixed deployment to best fit the requirements of your particular study and investigator base.

Case Report Forms

ClinTrialStat eCRF design has long been a core component  which we also provide as a stand-alone service. We have particular expertise and broad project experience producing eCRFs, patient diaries, and QOL questionnaires for large multi-language studies.

We first initiate the design process with an in-depth protocol analysis to completely identify all data collection requirements. Then, we construct a sequential workflow and page design package which seeks to strike an optimal balance among ease of site completion, efficiency of database entry, and reusability of forms across study visits and protocols. In addition, we work closely with your data management and clinical teams to produce an approved case book. All design work is produced in the ClinTrialStat eClinical software, eCRF Builder.

SAE Reporting and Database Migration

Our eClinical software is designed to perform safety surveillance reporting and migration validation processing of clinical databases destined for archiving in the OC environment. Our fully validated installation supports safety monitoring and assessment, automated generation of patient narratives, regulatory reports, and global safety database management. We also have the ability to construct parallel OC archival databases with full database setup and metadata loading as a value-added service.