512.782.8204 | info@slieagen.com
What We Do
In our partnerships with leading industrial researchers, we contribute to the path of disease eradication and healthy life.
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To meet your study needs, SlieaGen offers comprehensive clinical trials and biorepository services, which are highly complemented by our well-trained employees, and state-of-the-art technology.
Our services include an extensive inventory system complete with full traceability and comprehensive analysis. In addition to demographic information, including targeted medical history, SlieaGen provides data from FDA approved assays for measured analyte level and serology, industry-accepted genotype and subtype and sequence information for specific specimens.
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To help expedite the research process, we have sourced our biospecimens from continents around the world, including the Americas, Europe, Australia, Asia, and Africa to find the variety of specimens of importance to
our collaborating partners.
With a history of commitment and superior business ethics, our goal is to deliver the best products and services. Our Quality Standards are based on the industry’s best clinical practices with strict adherence to regulatory standards.
We strive to provide the highest level of customer service to satisfy our client expectations; going to great lengths - and occasionally very remote areas - to find the solution to your specimen requirements.
Biospecimens sourced from continents around the world!
Providing a variety of specimens of importance to our collaborating partners - sourced from 23 countries.
europe
the americas
asia
africa
australia
Our Services Include:
Clinical Research
We continue to provide Diagnostic and Therapeutic Expertise to progress towards a better tomorrow.
Our Research:
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We have successfully reached out and completed clinical studies in 23 different countries providing access to significant and rare patient populations that may cater to your research requirements.
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Expert monitoring of complex studies.
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We specialize in infectious diseases ranging from curable to life-threatening-- from Tuberculosis to HIV.
Infectious disease constitutes both a pressing reality and a foreshadowing of evolving healthcare concerns.
Quality Assurance
Maintaining Quality & Consistency
We Assure:
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Site audits and studies are conducted to FDA and ICH GCP standards.
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Beginning-to-end documentation from the Collection Site. From protocol development to IRB/IEC approval to sample collection and study close-out, all procedures are documented and filed as controlled records, therefore ensuring the authenticity of data collected.
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Principle Investigators and their staff, facilities and equipment are pre-qualified and monitored throughout the study.
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Monitoring records and procedures at sites, taking any necessary corrective actions.
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Auditing sites for compliance to ensure established policies are followed and are effective.
Strict adherence to Quality System Standards assures that SlieaGen can satisfy all necessary documentation for Regulatory submissions.
Data Management
The quality of data generated plays a key role in the outcome of a study.
We Provide:
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Easy to follow controlled documents to ensure understanding of study design and collection objectives and requirements.
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Well-designed CRF for clean and reliable data collection, an electronic version of the draft for client review, and an instruction manual provided at study sites.
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Diligent review of medical coding, especially coding of adverse events and concomitant drugs.
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Accountability and prompt delivery of time sensitive documents.
SlieaGen’s customized database assures fast response time in providing available inventory and sample characterization data and demographics.
Risk-based clinical monitoring fortifies confidence in the quality of our specimens.
Clinical Monitoring
Clinical monitoring the most critical area of drug trials.
We Monitor:
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Site management and monitoring regimen adhering to local regulatory requirements.
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Pre-investigational site qualification visits.
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Site initiation visits-- offering specialized training as per study specifications.
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Interim site monitoring visits.
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Site closure visits.
Regulatory Affairs
You can depend on us to manage your clinical research submissions in accordance with current Federal and local regulations.
We Conduct:
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Studies according to ICH-GCP & FDA guidelines.
By making one of our primary goals to work closely with patients and clients, we ensure your data is scientifically meaningful to clinical, regulatory and patient communities.
Get In Touch
Please let us know if you have any questions or would like to move forward with any of our services. We look forward to hearing from you!
phone #: 512.782.8204 | email: austin.sequeira@slieagen.com