Prometrika

PROMETRIKA provides IND/CTA enabling and planning stages support, strategy development, and execution of required activities using cross-disciplinary expertise.

Comprehensive pre-IND strategy and planning services including Clinical Development Plan drafting, regulatory authority meeting preparation, IND submission readiness, protocol drafting, biostatistical design, and natural history study design.

Innovative and nimble strategies for successful clinical development, providing fit-for-purpose clinical development plans for drugs, biologics, and devices.

Comprehensive development and management strategies for clinical development programs.

Clinical research services incorporating elements of adaptive design, allowing researchers to analyze data mid-stream, refine research strategy, and modify trial design without compromising scientific integrity.

Consultation services focused on adaptive trial design strategies.

Comprehensive technology consulting and integration services for clinical trials, including exploratory consultation, database integration, vendor management, validation, and user training.

Evaluation and implementation support for clinical trial technologies.

Creation of templates for clinical trial documentation.

Comprehensive full-service clinical research organization (CRO) services covering Phase 1 through Phase 3 clinical studies, including pharmacokinetic and pharmacodynamic (PK/PD) studies, clinical operations, biostatistics, and regulatory affairs.

Full or functional clinical services for phase 1 through 4 oncology trials across a wide variety of indications including solid tumors and hematologic malignancies.

Professional clinical data standards and statistical programming services providing submission-ready CDISC SDTM and ADaM datasets for regulatory bodies worldwide.

Biostatistics and programming services including insightful analysis, study design, protocol development, statistical analysis plan preparation, and CDISC SDTM and ADaM dataset generation.

Full-service clinical research and functional service provider solutions tailored for rare disease drug development, supporting over 100 clinical studies across diverse indications.

Innovative and thoughtful strategies for clinical development planning, study designs and regulatory submissions led by expert statistical consultants.

Professional medical writing services providing submission-ready protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), NDAs/MAAs, and other regulatory documents tailored to sponsor needs.

Full-service global clinical trial planning and execution utilizing an extensive global site network, harmonized SOPs, and localized regulatory and operational expertise across North America, South America, Asia, Europe, Africa, and Oceania.

Clinical trial consulting services executed by functional experts and highly trained teams for fit-for-purpose solutions.

Consultation and strategic support services for regulatory affairs and operations across the product development life cycle, including health authority interactions, submissions, and expedited pathways.

Comprehensive phase 4 services focusing on helping sponsors build product awareness, investigate new indications, fulfill post-marketing regulatory commitments, and collect real-world data (RWD) for real-world evidence (RWE).

Comprehensive clinical data management services including database build, data review, custom metrics design, eCRF development, medical coding, and database lock.

Oversight for functional areas and development of supporting processes.

Independent Data Monitoring Committee (IDMC) support and services.

Support for regulatory agency interactions, meetings, and submissions.

Planning and structuring staff requirements for clinical trial execution.

Specialized services supporting decentralized clinical trials to optimize patient engagement and trial logistics.

Custom programming services for Electronic Data Capture (EDC) systems.

Strategic consultation for partners looking to move from the pre-clinical to the clinical stage.

A tool for clinical data managers that makes local laboratory data management more efficient and accurate by flagging out-of-range values and converting ranges and laboratory values across sites to a standard unit.

Development of standard operating procedures for clinical trial execution.

Subject matter expert workshops to guide internal infrastructure setup.

Development of global case report form libraries for clinical studies.

Upversioning services for clinical coding dictionaries and data.

Development of cutting edge clinical trial protocols.

Support and preparation services to ensure inspection readiness for regulatory audits.

Evaluation of risk management strategies for clinical trial operations.

Independent auditing services for clinical trials and processes.

Analysis of natural history databases for rare diseases and clinical insights.