CLINICAL TRIALS
Eccolab Group provides world-class central laboratory testing services specifically tailored to each study protocol. With state-of-the-art technologies, Eccolab offers comprehensive laboratory service solutions that empower our clients to make fast decisions about their compounds.
SERVICES & SOLUTIONS
Eccolab delivers a unique array of laboratory services and solutions tailored specifically to each study and designed to maximize assessment support to Phase I-IV of research trials.
LABORATORY DATA
At Eccolab, we specialize in high-quality, actionable laboratory data that facilitates pharmaceutical development and FDA approval.
HIGHLY QUALIFIED TEAM
Our team consists of highly qualified laboratory professionals, scientists and doctors who provide an unmeasured level of support and expertise that you can entrust in.
Our central lab services guarantee high-quality testing results and data in real time across all phases of the pharmaceutical development.
Service Lineup
The Eccolab order-and-result portal enables the client and clinical team to order laboratory assessments and view results in real time.
Specimens and requisitions are bar-coded and electronic to ensure traceability and harmonization.
Our services range from basic screening assessments to more complex pharmacokinetics (PK) testing. Our laboratory solutions begin with the study protocol review, sample collection management, testing services and data reporting.
Each study is custom-tailored to meet the specific requirements of the study protocol. The Eccolab study coordinators are highly trained in clinical laboratory assessment and are available 24/7 to respond to the needs of the project.
Clinical Data Management
Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations.
Data Quality is the most important aspect of the pharmaceutical development. Due to this reason, Eccolab utilizes an Oracle® database platform to manage all study-related data.
Eccolab has very robust data management capabilities that enable seamless integration of your data. Our team of engineers supports in generating high-quality, reliable, statistically sound, reproducible and validated data for your trials.
We strive to provide regulatory compliant data that meet the demands of protocol-specific parameters.
Eccolab is compliant 21 CFR Part 11 with validated systems to ensure accuracy, reliability and consistency of the data capture.
Quality Assurance
Eccolab has planned and systematic quality and compliance processes in place that are established to ensure that the study is performed and the data generated, documented and reported is in conformity with Good Clinical Practice (GCP) and the applicable regulatory requirements.
These processes are forged by the guidance of Clinical Laboratory Improvement Amendments (CLIA), COLA Accreditation and standards set by Clinical and Laboratory Standards Institute (CLSI) in order to drive harmonization and efficiency. Our QA program is centered on a culture that promotes quality systems that include audits, evaluations, and continuous process improvements.
We endeavor to maintain efficient and reproducible processes that ensure the testing reported meets the scrutiny of the highest quality standards.
When it comes to clinical trials, quality and compliance is at the forefront of the Eccolab’s core values.
Data Transfer
Based on these, a Data Management Plan (DMP) is developed. DMP document is a road map to handle the data under foreseeable circumstances and describes the CDM activities to be followed in the trial.
Clinical Trial Services
Study-assessment visits are fully customized and packaged into order sets that are specific to each study protocol.
Our order/result portal solution allows for REAL-TIME, easy error-free and consistent order entry and result reporting capabilities for your indispensable research trial.
Screening assessments are reported in <18 hours daily.
