Biopharma Services
Table of Contents
Worldwide Clinical Trials Support
Over two decades of experience and over 400+ studies completed in Phase I-IV clinical trials support. We bring a unique combination of the understanding of the mechanism of disease, translating this to the specific needs of a clinical trial. Our Experienced pathologists & scientists ensure the most appropriate regulatory valid testing and high-quality results are produced. Then, our and experienced project & data managers ensure we deliver timely high-quality data on complex trials to ensure we help hit patient recruitment targets and deliver successful clinical trial outcomes by reducing time to FDA submission, minimizing risks of rejection and cost of trial.
Therapeutic Expertise
We offer a unique combination of understanding the mechanism of disease and the ability to expertly apply it to diagnostic patient care and clinical trial studies.
Our Pathologists and scientist have a deep domain knowledge and understanding in a range of therapeutic areas that include, Solid tumor oncology, (NSCLC, Head and Neck Cancer, Prostrate, Breast and Ovarian), Hematopathology, (AML, MDS, CLL, MM), GI Pathology, (Liver, NASH, cytology, Urology), and Dermatopathology. In addition, we have extensive experience in Infectious disease, Immunology and Inflammation, Genetic and rare diseases, Renal, Cardiac, Musculoskeletal, pulmonary and sepsis indications.
Geneuity CRS
Geneuity Clinical Research Services is a DBA wholly owned by Molecular Pathology Laboratory, Inc (MPLN) that encompasses the commercial operations, data management, and project services branches specific to the clinical research services division. The MPLN lab performs all testing services and handles all specimen logistic requirements.”
IVD/CDx Study Support
Our Expertise in CAP/CLIA molecular diagnostics, pathology, informatics, innovative solutions, and technologies ensures makes us an ideal choice to meet your IVD/CDx testing needs. We have over two decades experience with major instrument and diagnostic reagent manufactures in providing support for IVD/CDx studies. Our services include.
- Assay validation for 510K/PMA data collection
- Presentation of data to FDA advisory committee
- Partner for Companion Diagnostic Development
- Platform and Assay Correlation
- Clinical Interpretive Expertise and Result Consultation
- Method Development and Validation
Method Development and Validation
Biomarkers and complex clinical assays are recognized as essential tools for the development of therapeutics, allowing improved and better-informed clinical trial design through indicators of target engagement and those that enable patient stratification. Our Team can help design and validate new assays in our CAP/CLIA laboratory, undertake method transfers or migration modification of existing novel methods.
Our expert Board-certified pathologist and PhD scientific teams are on hand to provide protocol consulting, Biomarker selection / consultation, Biomarker assay development, Companion diagnostic selection / validation, access to pathology tissue and biobank resource, and support all aspects of your Phase I, II, III specialty laboratory testing.
Extensive Test Menu
Our expert group of board-certified pathologists and scientists can help assess biomarkers and complex molecular pathology testing panels for patient recruitment, stratification, and ongoing trial safety monitoring. Our team has over three decades of experience in operation as a CLIA-certified and CAP-accredited molecular diagnostic laboratory, providing a consultative and unique approach to clinical trials R&D and IVD study laboratory testing.
Digital Pathology & KOL network
We have an experienced Key opinion leader (KOL) network that is spread across two continents and multiple countries. We bring you experienced pathologists together to support your clinical trials worldwide. Our KOL experts cover Hematopathology, molecular genetic pathology, surgical pathology expertise, solid tumor oncology, GI pathology, Cytology and Dermatopathology.
Harnessing the power of our Aperio Digital pathology system, we can connect this expertise into a seamless global network to rapidly read and report data from your clinical specimens. Our system can allow multiple or blinded pathology reads, plus adjudication. Data can also be exported to image analysis and AI type algorithm systems such as Visio pharm and Halo.
Digital imaging also brings our clients new possibilities to support decentralized clinical trials and reduce logistics costs of shipping glass slides around the globe.
Project & Data Management
Our expert clinical project and data managers are your key contacts and partners to ensure your clinical trial sites, and your clinical and data teams are supported at every stage of the project lifecycle, from start up, study kick off, initiation, screening, enrolment, on study testing, to study close out and data base lock. At every key milestone for the duration of the project, our customer focused teams keep you informed on budget and up to date on progress.
All our project managers have significant scientific backgrounds and experience in complex research based clinical trials and work hand in hand with our scientific, client services and commercial operations teams to support and delivery high quality regulatory compliant testing results on time at every step of the project.
The key to a successful clinical trial is accurate clean quality data and our team of data mangers provides you with data in customized formats exported to your data management teams from our in house LIMS system.
Contact MPLN Biopharma Services
If you require any assistance, please don't hesitate to reach out to one of our customer service representatives today.