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At PMI, we know that client budgets and project objectives
vary. Therefore, our software and hardware IT capabilities
are designed with an eye toward scalability. This enables
us to provide options best suiting our clients’ clinical
data and information processing needs.
Web-enabled Technologies
Our eCDM applications are developed and maintained
through our partnership with ClinPhon,
a developer of Internet-based applications to facilitate acceleration
of clinical trials with proven software for study design,
data capture, and data management.
Clinical database design can be performed rapidly and query
development/validation can be done in real time. User training
is provided and documented using ClinPhon’s Accelerated
Learning™ on-line training platform. Clinical data entry
can be done in a controlled, timely manner. Data monitoring
and query generation/resolution may be completed well in advance
of site monitoring visits. And, there is 24/7 data access
and review for assigned users throughout the duration of a
trial.
Study administration is also enhanced by the availability
of secure, study-specific, collaborative web portals for email,
documents, data extracts, study metrics, and news items.
Clinical Programming
PMI’s experienced systems analysts provide programming
support in compliance with 21 CFR Part 11 for seamless collection,
storage, and extraction of clinical study data and information.
Data Management
Effective data management services facilitate efficient
access, processing, summarization, and dissemination of data
and information. At PMI, our data management services incorporate
leading-edge technology, 21 CFR Part 11 compliant systems,
and experienced clinical data management personnel to support
both electronic clinical data capture (EDC) and traditional
Case Report Form (CRF) double data-entry applications.
Our data management services are scalable to your needs and
emphasize well-organized, appropriately documented, accurate
and timely processing of your clinical data. Service areas
include:
- Case Report Form (CRF)
Design
Using the study protocol, PMI's Data Management Team
prepares and formats data collection forms indicating
study data fields to be collected and, where appropriate,
allowable responses for each field. Consideration is
given to design the CRFs in a user-friendly manner in
order to minimize entry errors, and study CRFs are formally
reviewed by the client prior to implementation.
- Clinical Data Management
Plan
Using the approved study CRFs, PMI develops detailed
database design specifications (DDS) for each client's
clinical study database. Each DDS includes the form
name, event name, event structure, data field definitions,
code-list and automated edit checks. Based on the DDS,
PMI team members prepare the written data management
plan, which includes CRFs, annotated CRF, Group and
User Set-Up Request Forms (for EDC study), Risk Analysis
assessment, Database Development Checklist, Database
Validation Plan, User Acceptance Test Plan, Data Processing
Guideline, In-House CRF Review Guideline, Data Cleaning
Guideline, Validation Report, User Acceptance Test Report
and Database Lock Check List. Data management plans
are formally reviewed by PMI and our clients at least
bi-annually and maintained using version control.
- Clinical Database
Development
PMI's clinical databases are based on a Microsoft SQL-based
platform. Study-specific data entry screens, back-end
tables, and automated edit checks are programmed and
validated in accordance with the data management plan
and 21 CFR part 11 requirements.
- Clinical Data Entry
With PMI’s EDC system, study data is entered
via a secure Internet connection by the study coordinator.
Pre-programmed automated edit checks are utilized to
provide controls for data entry accuracy. During site
monitoring visits, data entry accuracy is also confirmed
by the visiting clinical research associate.
With PMI’s paper CRF
system, completed CRFs, reviewed and collected in conjunction
with monitoring site visits, are forwarded to PMI where
they are logged and entered into the database. Double
data entry is performed by two different data entry coordinators,
and discrepancies are adjudicated prior to finalization
of entries. Data entry personal are trained on the specific
data processing guidelines, and pre-programmed automated
edit checks are utilized to provide controls for data
entry accuracy.
Meanwhile, PMI's EDC paper
double entry functionality provides flexibility to
sponsors who prefer a hybrid method of data collection.
Clinical Data Review &
Query Resolution Data inconsistencies that are not
detected by automated edit checks are reviewed per
the In-House CRF Review Guideline. Using either paper
or electronic DCFs, additional queries may be generated
and transmitted to the study site.
PMI’s clinical database
allows for tracking of CRFs received by site and by
subject. Additionally, each DCF generated and its
associated resolution status is tracked.
- Data Dictionary Processing
PMI provides data coding services for adverse events,
medications, and medical history. Typically using MedDRA
and WHO DRUG, coding listings can be provided regularly
for sponsor review.
- Data Imports
Written data import protocols are co-developed with
the central lab or reading center and submitted to the
sponsor for approval.
- Data Exports
Using PMI's clinical study management, data can be
easily exported into a number of formats including Excel
spreadsheets, SAS datasets, ACCESS tables and ASCII
files.
- Data Quality Assurance
Typical data quality assurance procedures include generation
and review of data inconsistency listings, confirmation
of randomization schedules, data entry versus source
data and resolution of data queries. Additionally, ad
hoc data reports are developed to provide study data
analysis and metrics to clients, as required, on an
ongoing basis throughout the study conduct.
- Database Lock and
Data Transfer
Upon successful completion of necessary data quality
assurance procedures and a data lock checklist, PMI
locks the clinical study database and the data is transferred
to the designated biostatistician for analysis.
- Database Maintenance
and Archival
PMI maintains clinical databases for the duration of
the project, and typically through completion of the
final clinical study report. Subsequently, clinical
study data is transferred to our client in their designated
format and archived as specified in the project agreement.
- Security Procedures
Clinical data security is enforced via use of a single
user/password sign-on for qualified, registered database
users. Specific access roles are granted as appropriate,
and user passwords are changed at specified intervals.
Audit trails of server and record access provide comprehensive
tracking of modifications made to data or programming
files.
PMI’s systems are configured to facilitate rapid restoration
of data in the unfortunate event of server failure. Clinical
data and programming files are stored on servers located in
a secure, environmentally controlled area within PMI’s
corporate office in Costa Mesa, CA, and backed up daily at
an off-site hosting facility, which uses standard best practices
with respect to data security.
Biostatistics and Clinical Programming
Clinical studies are performed for a variety of reasons
— preliminary evaluation of safety (first in human,
dose escalation, etc.), assessments of efficacy (comparisons
of dosage levels, comparisons vs. gold standard, etc.), or
performance/user preference comparisons versus alternative
products or treatments. Regardless of the study objectives,
statistical expertise is critical to running a successful
trial that will yield valid results.
At PMI, our statisticians and clinical programmers have experience
with trial design and data analysis across a broad range of
medical specialties and therapeutic areas. They have been
involved in various types of trials, including preliminary,
early-phase studies, pivotal studies for regulatory submissions,
and post-approval/marketing studies. PMI provides statistical
and clinical programming support for each stage of the clinical
study process — before, during, and post-study.
Pre-Study
Careful planning in the design phase will not only
provide that the data collected can be used to evaluate the
study hypotheses, it can also increase efficiency and decrease
costs. More…
During the pre-study stage, we provide:
- Input on clinical study design: Providing
a statistical perspective as to the appropriate models
for study design and objective study endpoints
- Sample size and power analysis: Determining
the number of clinical study subjects necessary to appropriately
evaluate study hypotheses
- Protocol development: Collaborating
with the clinical team and sponsors to develop the statistical
sections of the protocol and to ensure that study endpoints
are appropriately collected for the analysis of study
objectives
- Randomization schedule development:
Minimizing the likelihood of study enrollment bias
- CRF Review: Confirming that data is
captured in an appropriate manner in light of planned
safety and efficacy analyses. Careful review by Biostatistics
and Clinical Programming will also provide that data is
captured efficiently so that a quick turnaround from data
entry to analysis results, with a minimum of queries and
data clarifications, is possible.
During the Study
Once a trial has begun, the Biostatistics and Clinical
Programming Team can provide a variety of services so that
valuable inferences can be drawn from the data at the conclusion
of the study. More…
To assist in the analysis of the data, we offer:
- Statistical methodology consultation:
Determining the appropriate statistical tests, providing
input on the types of tables and graphs best suited for
summarizing the study endpoints, re-evaluating study assumptions,
and making appropriate modifications to the analysis as
necessary.
- Statistical analysis plan (SAP) development:
Providing pre-specification and documentation
of the planned analyses in a comprehensive SAP in order
to maintain the validity of statistical results. The SAP
typically includes operational definitions of endpoints
to be analyzed, rules for data handling and for inclusion
into the various analysis populations (intent-to-treat,
per protocol, safety, etc.), description of statistical
methodology, identification and presentation of shells
for planned statistical tables, figures and listings.
- Analysis dataset specifications: Developing
specifications for the analysis datasets to document the
algorithm used in creating analysis variables
- Interim statistical analyses: Performing
pre-specified interim analyses for regulatory bodies,
safety monitoring boards or as otherwise requested by
the sponsor
We also work with the Data Management Team to conduct a
careful, ongoing review of data as it becomes available
to create a smooth transition to database lock and the generation
of tables, listings and graphs. To assist in the review
of incoming data, we offer.
- Customized data listings: Enabling
independent parties to conduct blinded or un-blinded safety
reviews or facilitating the Sponsor’s data cleaning
processes
Post-Study
After the clinical data has been entered and cleaned,
the Biostatistics and Clinical Programming Team work together
to determine whether or not the study’s objectives have
been met. More…
At the conclusion of the study, we provide the following:
- Final statistical tables, listings and figures:
Generating tables, listings and figures from the locked
database in a format that can be easily incorporated into
a final report or presentation
- Review and interpretation of statistical results:
Interpreting statistical results to facilitate the understanding
of the data analysis and provide guidance to medical writers
on the implications of the statistical results
- Ad-hoc exploratory analyses: Providing
additional analysis of the data as indicated by the initial
study results
Additional Support More…
In addition to the services we provide for formal clinical
studies, PMI’s Biostatistics and Clinical Programming
Team offer assistance for:
- Scientific presentations/journal articles: Providing
statistical consultation and clinical programming support
for scientific abstracts, presentations or articles submitted
to conferences or publications
- QC of tables and analysis datasets: Providing an independent
accuracy check of Program Sponsor’s tables and analysis
datasets based on the SAP and analysis dataset specifications
Quality Control More…
PMI’s quality control procedures for statistical
output involve a combination of independent programming
and internal review to verify accuracy and completeness
of tables, figures, and listings.
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