FIRMPLACE

Data Management

Firmplace provides expert clinical data management services offering a wide variety of services for clinical studies. We implement advanced technology solutions to provide accurate and reliable CDM services.

Our data management team with more than 10 years of experience provides data management services from study start-up to study close-out. The Data Management personnel are experienced in a range of clinical trial phases and therapeutic areas and have expertise in Paper Based and EDC/RDC trials. WE offer a full spectrum of data management services and expertise to ensure the efficient and appropriate management of your clinical trial data. We are well trained and rigorously follow GCP, Standard Operating Procedures (SOPs) that encompass security and industry regulations.
We work closely with clients to ensure conformity with standards, procedures and timelines. Our team can work with your standards and procedures or we can supply our own model, developed through the experience of more than 10 years of supporting clinical research trials.
We initiate with the creation and maintenance of process documentation. Firmplace provides 21 CFR part compliant CDM services in the following segments as well:

·         Data Management Plan (DMP) creation

·         Database development

·         Data entry and validation

·         Data cleaning

·         External data loading and reconciliation

·         SAE reconciliation

·         Dictionary coding - MedDRA and WHO Drug

·         Database lock

·         EDC‐specific Service and Support

·         Streamline EDC Account Management

·         EDC Training

·         EDC Start Up and Conduct Support

·         CRF design

·         CRF annotation

·         Creating annotated specification forms

·         CRF Completion Guidelines

·         UAT

·         Database review delivered in SAS, XML, or other formats

·         Quality Control (QC) sampling for paper-based studies
 

CDASH compliant CRF design deliverables:

     The quality of the data collection at the site can be improved by designing standard CRF. We implement the best practice and standards specified in CDASH by using standard library of CRF modules and formats specific to the therapeutic area in 5-7 business days. Also extensive review of CRF to protocol is done by the review team to make sure that the correct data fields are captured.

 

Development of Study Validation plan for data cleaning:

    The FP team thoroughly reviews the protocol while developing the study validation plan to ensure that all critical safety and efficacy parameters are specified. These checks are further programmed by our programmer team to raise the alert messages when the data collected is not as per the data definition. A certified programmer who also has 6 year of data management experience defines and programs all edit checks to fit the study requirements and builds the study database within tight timeframe.

 

Firmplace has been a CDISC Registered Solutions Provider since 2012:
 Legacy Data Conversions to SDTM standards
 SDTM annotated CRF
 SDTM mapping specifications
 Conversion of legacy raw datasets to SDTM dataset
 SDTM compliance checks using OpenCDISC
 

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