DESIGN OF CLINICAL TRIALS
• Design of clinical trials including comprehensive consideration of quantitative aspects (including design framework, sample size adjustments, randomization adaptation, historic data integration),
• Efficient and innovative designs: Adaptive, Bayesian, etc.,
• Analysis of historic information to inform the study design,
• Endpoint and population considerations,
• Other specific aspects impacting the trial design.
DATA COLLECTION AND INTEGRATION
• Electronic Data Capture (EDC) creation and support,
• Accurate data collection with specialized tools and software developed and adapted for each specific project,
• Integration of other external sources of information into a single platform.
DATA MONITORING ACTIVITIES
• Risk based monitoring including real-time monitoring of whole study data to identify data quality, integrity and site monitoring issues and provide solutions in a timely manner,
• Remote site monitoring,
• Clinical Audit Scheduling and Schedule optimization,
• Statistical monitoring to enable adaptive designs with respect to population, response adaptation, sample size adjustments etc.
STATISTICAL ANALYSIS
• Decision making information generation during interim analysis,
• Development of Statistical Analysis Plan (SAP),
• Go / No-Go Criteria,
• Preparation of final tables, listings and figures,
• SAS Programming and creation of submission datasets for the regulatory authorities (CDISC, ADaM, SDTM),
• Comprehensive Data Analysis.STRATEGIC CONSULTING
• Strategic Consulting for clinical development and regulatory support, for a wide variety of therapeutic areas, treatment types, diagnostic tests and medical devices,
• Regulatory support including preliminary communication with regulatory authorities (FDA, EMA, AEMPS or other), submission package creation, submission support, post-submission communication.
About us
PCT Lab Research is an innovative, research-oriented Clinical Research Organization (CRO) focusing on design and all quantitative aspects of early stage clinical trials. It is headquartered in Barcelona, Spain.
The mission of the company is to utilize primarily scientific aspects of clinical trials with a patient‐centric approach. Operational aspects, such as patient and patient compliance, data reporting, transfer and management are critical to the company for obtaining valid and interpretable analytical and clinical data.
PCT Lab Research, along with three other companies: ClinSoft, ElmTree Research, and TrialSight are representing four satellite companies of ClinStatDevice (Boston, MA), with each one focusing on specific areas of healthcare, clinical research and technology.
One of the objectives of the unit is to carry out business development activities and provide services/collaboration/solutions to Pharma, Health, Biotech companies and CROs located in Europe.
The company provides non-trivial and study specific/tailored design, analytical and IT solutions to maximize the integrity of the study and its chances to succeed. All provided services and software are of highest standards in industry. The company’s security and integrity standards are ensuring the subject and data safety and are fully compliant with HIPAA, Title 21 CFR part 11 and GDPR.
PARTNER NETWORK
PARTNER WORKS
Our network of partner companies has completed over 15 clinical studies in 2018. It includes recent FDA approval of TEG6S medical device on the basis of a pivotal clinical study utilizing adaptive design and extensive tailored IT, which enables Risk Based Monitoring and Database reconciliation.
Keep in Touch
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173 Calle Balmes, 08006, Barcelona Spain
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+34 663 62 6374 +34 617 480 7727