At Translational Biotech Solutions, we provide end-to-end consulting and project management to advance therapeutic programs from discovery through clinical readiness. Our services include comprehensive R&D strategy, preclinical study oversight, CRO coordination, regulatory planning, and data analysis, tailored to streamline and support each stage of development. Our expert team provides tailored support across preclinical studies, regulatory strategy, and data analysis, ensuring seamless progress from concept to clinic.
Access deep scientific knowledge and broad R&D experience to operationalize or optimize your program.
Technology Assessment
Evaluate cutting-edge prediction-based workflows and HTS technologies to enhance target identification and validation.
Assay Development - Discovery / Lead ID
Design and optimize robust, reproducible, and accurate, assays for identifying and validating targets and selecting optimized lead compounds.
Assay Development - In Vitro Pharmacology
Design in vitro studies to characterize the pharmacodynamics and specificity of lead compounds.
Early Toxicology Studies
Plan initial toxicology assessments, ADME and DMPK studies.
Biomarker Discovery
Identify and validate early biomarkers of target engagement and efficacy, laying the groundwork to capture clear clinical proof-of-concept.
In Vivo Efficacy Studies
Design in vivo studies in relevant animal models to assess the therapeutic potential of leads.
Ex Vivo MOA & Biomarker Validation Studies
Coordinate ex vivo studies to elucidate the mechanism of action of lead candidates and validate PD biomarkers.
Analytical Method Development
Develop and validate robust analytical methods.
Translational PK/PD
Use PK/PD modeling to optimize dose and regimen.
Toxicology / Toxicokinetics (TK) Studies
Design IND-enabling toxicology / TK studies.
Clinical Biomarker Strategies
Develop biomarker strategies to gain clinical Proof-of-Concept data and support exploratory clinical endpoints.
Identify a CRO for your project or trial, or work with our trusted vendors. Our hands-on collaboration management experience gets you reliable data quickly.
Identify and select the optimal preclinical, translational, or clinical CRO based on project-specific needs, ensuring alignment with technical and budgetary requirements.
Conduct thorough audits to assess compliance, quality, and risk factors before and during CRO engagement.
Negotiate clear, comprehensive contracts and scopes of work to define expectations and protect interests.
Hands-on oversight and coordination to ensure CRO projects meet milestones, timelines, and quality standards. Quickly identify and resolve issues to prevent project delays and maintain progress. Manage and optimize the CRO relationship for ongoing performance and project success.
Ensure accuracy, completeness, and regulatory compliance in all data and reports generated by the CRO. Maintain rigorous QA and ensure regulatory alignment throughout the CRO's execution of the project.
Develop key documents and submit them with confidence.
Design tailored regulatory strategies to navigate complex approval processes efficiently.
Develop precise, compliant protocols to guide clinical trial execution and ensure regulatory approval.
Draft clear, patient-centric consent forms that meet ethical and regulatory standards.
Compile comprehensive, accurate investigational product dossiers for trial investigators
Prepare and submit Investigational New Drug (IND) and Clinical Trial Application (CTA) documents in full regulatory compliance.
Prepare and submit Investigational New Drug (IND) and Clinical Trial Application (CTA) documents in full regulatory compliance.
Create comprehensive drug manuals that provide detailed instructions on the storage, handling, and administration of investigational products. Develop clear, standardized laboratory manuals to ensure consistent handling, processing, and analysis of clinical samples.
Review all documents for adherence to regulatory requirements and readiness for submission.
Facilitate effective communication with regulatory agencies to address questions and expedite approvals.
Understanding the data is critical for program success. Our independent analysis and reporting of your data adds clarity and confidence for you and regulators.
Apply appropriate analytical techniques to transform raw data into meaningful insights. Translate complex data into actionable conclusions that drive decision-making.
Gain expert statistical guidance to ensure robust and accurate data analysis.
Create clear, compelling visualizations to effectively communicate data insights.
Craft comprehensive, clear reports that accurately reflect findings and support regulatory submissions. Gain critical reviews of study reports to ensure consistency and alignment with program objectives.
Implement QA processes to ensure data integrity and reliability.
Connect and manage interactions with expert consultants and KOLs to develop, refine, or optimize program strategy.
Align novel technology platforms with the most promising indications based on market need and scientific feasibility.
Ensure target and disease selection aligns with company goals and market opportunities.
Identify potential scientific, technical, and market risks associated with selected targets and platforms. Develop strategies to mitigate identified risks.
Identify potential partners and partnership strategies.
Identify and select manufacturing partners and plan GMP-scale-up to meet the needs of proof-of-concept trials.
Develop a supply chain strategy to ensure the timely availability of clinical trial material.
Develop a streamlined preclinical program and regulatory interaction plan to support first-in-human (FIH) trials for the appropriate regulatory framework.
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