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Why A. P. R., Inc.
Additional No-Cost
Client Services
Candidate Screening
Process
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Biotech /
Pharmaceutical
Bio-Informatics Technology Consulting
A. P. R., Inc. was created in 1993 with the
sole purpose of providing a full range of recruitment and consulting services. Alpha
Professionals maximizes client potential and growth by
providing highly trained and qualified personnel. We have recently created a
Bio-Informatics Division. Acting as a Contract Research Organization, the
Bio-Informatics Division can now work with client projects off-site and
complete the assignment in a timely manner. Utilizing Alpha Professionals’
resources and personnel, we can now assist clients throughout every phase
of the clinical trials process by providing SAS Programmers,
Biostatisticians, Medical Technical Writers, Clinical Data Managers, and
Clinical Research Associates that work parallel to client on-site management
as well as
off-site.
Alpha Professionals staff meticulously recruit, screen, interview, evaluate
experience, verify references, initiate background checks and administer an
Biotech/Pharmaceutical
Total Quality Management ISO9000 Certified Skills Testing per client request.
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SAS Programmers:
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Work at
all levels from basic programmers to Lead Programmers.
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Work in all phases ( I - IV) of clinical
research filings.
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Create Safety and Efficacy customized reports
for FDA submissions.
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Create tables and listings for Electronic
Regulatory Submission using SAS programming techniques (i.e., Open Delivery
System techniques), as well as Adobe Acrobat software to hyperlink reports
to various Documents, tables and data sets.
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Write numerous programs using SAS/ MACROS,
SAS/BASE, SAS/STAT, SAS/GRAPHICS.
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Our consultants are adept with NT, UNIX (linux,
Sun/OS, Solaris, AIX), MVS, VAX/VMS, Mainframe, Client Server, Sybase, DB2,
Informix, as well as a host of other specialized platforms.
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Possess Degrees in Statistics, Mathematics or
Computer Science.
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BioStatisticians:
Alpha Professionals Statisticians are proficient in all aspects of
clinical research from protocol development and study design through final
statistical analysis of regulatory submissions.
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Work closely with medical teams to prepare
statistical analysis plan for a study, and/or design study protocols.
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Perform sample size calculations.
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Prepare statistical write ups for New Drug
Application filing.
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Provide interval study analyses for ongoing
safety and efficacy updates.
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Possess a Masters’ or PhD Degree in
BioStatistics with five years minimal clinical trial experience.
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Medical Technical
Writers:
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Have contributed to NDA submissions, package
insert development, marketing statements and other Research oriented
projects.
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Interact directly with statisticians,
administrators and project members to produce documentation that supports
the intended thesis and existing clinical data.
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Are experienced in all phases of clinical
research (I – IV).
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Perform Validation of Reports, Clinical
Summaries. Regulatory Writing, Document Design, and Document Editing.
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Prepare electronic submissions.
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Data Managers:
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Data
Managers use study protocols and case report forms to build database schemes
and design both computerized and manual checks to assure accuracy of
clinical data as well as conformance to study protocol.
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Assist clients in refining checks and
identify documentation problems.
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Generate query responses, edit and correct
data via query responses and protocol addenda.
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Performs checks on adverse events involving
other drug interaction and protocol medications.
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Are adept in domestic and international
studies, when required.
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Validate clinical trial data, identify
inconsistencies, initiate resolution of data problems, creating customized
reports, and performing ad-hoc queries.
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From annotated Case Report Forms, generated
complex ORACLE and/or SAS code to query, validate data, and generate
reports.
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