Our consultation services focus on overcoming the challenges faced to get products to market. Our scientific and operational expertise in non-clinical testing and in clinical trial pharmacodynamic testing translates into making more informed go/no-go decisions.
With a reputation for solving complex issues, providing specialty lab testing and sample management solutions, MLM Medical Labs is a recognized leader with global experience.
Consultation services include Early Stage Drug Development, Clinical Trial Design and Protocol Development, Site Laboratory Training and Monitoring, Health Professionals Education, Technical Writing, and Quality Assurance.
Clinical Trial Design and Protocol Development
We utilize our extensive and cross-functional scientific expertise to provide support for clinical trial design and protocol development. By forming an early partnership with clients, we are able to advise on important protocol elements (specific biomarkers, assays, blood collection procedures, etc.) that will ultimately have a positive impact on study success. Developing this specialized protocol content provides the best opportunity to save sponsor’s time, reduce risks and costs, and maximize clinical study outcomes and data utilization.
The following is a short summary of MLM offerings related to clinical trial design and protocol development:
- Expert scientific knowledge essential for the development of specific protocol elements
- Study laboratory manuals to accompany the clinical protocol
- Comprehensive sub-study protocol design and implementation
- Laboratory equipment loaner program
- Investigator meeting support
- Informed consent form design
- Case report form design
Site Laboratory Training and Monitoring
MLM Labs provides monitoring services for smaller, specialized trials or projects that may require concentrated priority attention or intensive pharmacodynamic testing. Our highly trained and experienced staff ensures protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites.
Our monitoring services are designed to insure successful navigation through the clinical trial maze:
- Site evaluation, site initiation, routine monitoring and close-out visits
- Review of the informed consent process, and assistance with IRB/EC approvals
- Essential document management
- Clinical study project and material accountability
- On call site laboratory troubleshooting
Health Professionals Education
Due to the years of experience and continued engagement with academia and industry, our scientists and health care professionals may provide education to academic departments, pharmaceutical companies, and health care professionals. Our educational programs (lectures or roundtable discussions) provide insight on newly approved agents in the hematological or hemostasis and thrombosis fields, cutting edge technologies, or biologic or mechanistic aspects of new drug targets. Our activities are applicable to either CME or non-CME accredited programs.
Clinical Research Reports and Manuscripts
MLM Labs has extensive experience in publishing abstracts and manuscripts in peer-reviewed journals, and in the presentation of posters and exhibits at scientific meetings. We offer technical writing as part of a comprehensive service program.
We are experts in the following areas:
- Medical/scientific literature review
- Expert clinical research reports and executive summaries
- Data reports
- Abstracts, posters, and manuscripts
- White papers
MLM Labs conducts systematic and independent examination of all trial-related activities and documents. These audits determine whether the evaluated activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures (SOPs), and Good Clinical Practices (GCPs).
Our quality assurance services include:
- Customized procedures for sample processing
- Regular teleconference/WebEx meetings with clinical sites and sponsor
- Clinical site inspection and validation for PD, PK, and genetic sampling
- Case Report Form review, query generation, and query resolution with sites
- On-site training