Pearls.Clinic

Subject Matter Experts with vast experience in the clinical development of drugs and medical devices. Providing healthcare software development companies, with expertise in all aspects of clinical research. Our experience could provide great support in the development and improvement of software, platforms, and tools used in the current R&N environment. We have teamed with a small team of IT experts with long robust delivery experiences in medical information systems. 

Mission

Our goal is to help small pharma and biotech companies in clinical development by guiding them through clinical research and providing IT solutions for specific needs. We aim to work with big pharma and biotech in providing custom made IT solutions.

Portfolio

Our working commercial experiences include INC Research, Icon, PAREXEL, Covance, Worldwide Clinical Trials, Pfizer, UCB Pharma, Sanofi, Biogen, Yamanouchi, LG Life science, Roche Pharmaceutical, Geneuro, Otsuka pharmaceutical Co, Acadia, Takeda, Eisai, Altana Pharma, Abbvie, Allergan, and numerous other pharma, biotech and medical device companies and CROs.

Services

Success Analytics

Big data is the core of medical research. Since clinical studies face strict protocols, unpredictable delays, and pressure for low costs, sponsors, and contract research organizations (CRO) need robust data to succeed. Synthesized and abundant medical information can help researchers deal with the complexity and demands of today’s medical research.

Multifaceted datasets

Clinical trials rely on multifaceted datasets and clinical trial performance analytics to improve drug development, health outcomes, and revenue. Clinical trial performance metrics provide information across systems to track execution, manage logistics, and detect risks across multiple sites and regions. To be more precise, performance metrics can be defined as discrete units of research information, which can be employed to benefit internal and operational performance, as well as interoperability. Performance analytics can reshape the future of research.

Data points

Valuable clinical trial performance metrics, in particular, are data points that incorporate quality assessment and predictive modeling techniques. They provide insights into operational performance and quality. Such data can be used to improve operational planning and quality

We help in delivering accurate insights to senior management and decision-makers. Enabling quick but resilient decision making.

Risk Management 

Risk identification, assessment, and mitigation are a sine qua non of modern clinical research. Risk assessment is an integral part of risk management. In practice, assessing risks is difficult but clinical research professionals must become acquainted with the concept of risk assessment in order to reap the full potential of risk management.

Assessment

The risk assessment should be done by a competent team of individuals who have a good working knowledge of the critical processes that support subject safety, trial integrity, and data quality. Indeed, being aware of things such as the enrolment process, the procedures to be performed, the general health status of subjects, and how data are to be collected is essential for identifying critical processes.

We make it possible to mitigate Clinical Trials risks, by introducing a Risk-Based Quality Management System incorporated in our custom-made CTMS.

Compliance Oversight

In the reactive phase, organizations tend to be incident-driven, where problems cause setbacks and organizations are constantly fighting fires. In the enforcement phase, organizations tend to be audit-driven, as there is quality governance, CAPA implementation, and segregation between operations and compliance. In the awareness phase, companies are metrics-driven, as processes start to harmonize, there are active CAPA processes and quality-driven process improvement. In the controlled phase, enterprises tend to be risk-driven, as interactive compliance management controls exist, and active risk management becomes implemented (most likely with the use of technology). Lastly, companies in the performance-driven phase tend to drive quality and compliance through business performance, compliance becomes an essential part of clinical operations, and the compliance group proactively becomes a mentoring entity.

The overarching goal of our consultants is to enhance human subject protection and the quality and integrity of clinical trial data. Compliance oversight is provided through analysis of trends in compliance of clinical research sites, protocol compliance, regulatory and GCP compliance.

The overarching goal of our consultants is to enhance human subject protection and the quality and integrity of clinical trial data. Compliance oversight is provided through analysis of trends in compliance of clinical research sites, protocol compliance, regulatory and GCP compliance.

Central Planning

Planning a clinical trial requires overcoming a series of steps for each deliverable that is rather standardized. Some steps are milestones in the process. The same holds for funding. The successful execution of a clinical trial means the project is finished on time, on budget, and has a high level of quality. It only figures then that these objectives should be clearly defined before initiating any project.

Before defining time, budget, and quality metrics, a comprehensive project plan is required, otherwise objectives will not be realistic.

The Method

The main purpose of planning is to anticipate all possible actions that will take place throughout the project. The complexity of today’s trials makes such a diagnosis for each aspect of the study (in order to set realistic project objectives) imperative.

We assure all the planning components are thought through according to the best practices from Pearls.Clinic mature methodology

Software Engineering

Our partner team of seasoned IT engineers is delivering robust MIS related products since 2005.

Get in touch

Address

1a Gertrude Street,
London, UK, SW10 0JN

Opening hours

Monday – Friday: 9am – 7pm
Saturday: 9am – 10pm

Contact us

+44 56 03 07 11 43

info@pearls.clinic

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