ABOUT CLINICAL INK

Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress. Visit clinicalink.com.

CONTACT INFORMATION

Clinical Ink

110 Gibraltar Road, Suite 150

Horsham, PA 19044

UNITED STATES

FEATURED ARTICLES

  • But what defines hybrid trials? And what are the best practices and best resources to really make them work? The foundation is eSource – more specifically, direct data capture. This blog explains what DDC is and how it’s really the only methodology that will afford you the flexibility, speed, site efficiency, and data quality you need to make your trials successful.

  • While decentralized trial models and ePRO are both accepted in the industry, some sponsors have hesitated on BYOD due to questions over data quality, integrity, and variability; regulatory acceptance; and logistical issues. This article dispels common myths about BYOD.

  • Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) to improve data quality and integrity. Eligibility decisions based on data  derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. This paper describes the complexity of GI trials in detail and shows a solution that is designed to overcome their significant, but typical, challenges.

  • In oncology clinical research, patient reported outcomes (PRO) have historically been collected on paper. This white paper describes a unique, agile ePRO deployment methodology used by a global clinical trial technology company, discusses the benefits of using ePRO in oncology trials, and explains why this agile process is beneficial for oncology trials.

  • The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Read more about the Advantages and Misconceptions of BYOD and what you should consider if you are deciding whether BYOD is an option for your study.

  • You need streamlined, intuitive ePRO and ClinRO technology that expedites oncology workflows, lessens the burden on patients, and saves caregivers time. This blog explains how Clinical Ink’s robust, configurable platform connects sponsors, CROs, sites, and patients, fostering better cancer research and a higher standard of care.

  • The needs of the clinical trial protocol — not the limitations of technology — should determine how a study is deployed. That said, until now, data collection technology has constrained data collection and review. To achieve a flexible, patient-driven design, we needed to make our system even more powerful and adaptable.

  • CNS and pain trials are demanding from a data capture standpoint: Complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients all must be overcome. After consulting with key opinion leaders from CROs and pharma we learned the solution was a product with a well-thought-out functionality specific to the therapeutic area coupled with highly consultative, experience-based guidance that ensures clients receive a complete data collection solution that fulfills their exact needs.

  • The accelerating complexity of gastroenterology protocols has exceeded the capacity of most electronic clinical outcome assessments (eCOAs) — including both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs) — to adapt. Patients are overwhelmed, sites are overburdened, and sponsors struggle with data quality and integrity.

  • There’s a lot of confusion surrounding eSource. What is it? How is it used? What’s wrong with the way I’ve been
    recording my data since 2007? Here, we aim to clear the muddied waters.

  • Life science companies are under increasing pressure to execute clinical trials faster with higher quality.  Read survey results that show as the Lumenis platform adoption increased, study teams began to see an improvement in data quality, operational efficiency, and ease of use compared to traditional paper and EDC methods.

  • For sponsors and CROs, clinical trials for systemic lupus erythematosus (SLE or, more commonly, lupus) present a specific set of challenges that can impact the recruitment of investigators and patients and inhibit the ability to collect accurate data. This white paper discusses the challenges of diagnosing lupus, the unique difficulties lupus clinical trials face, and how the innovative eLAS platform helps meet these challenges.

  • As the size, number, and complexity of clinical trials continue to grow, the standard approach to monitoring — a resource-intensive approach involving regular site visits and source document verification (SDV) — has become costly and is no longer realistic. However, the fundamental principles — protection of participants and assurance of data quality — remain paramount. Implementing an RBM strategy at your organization does not need to be complicated. This paper outlines several key strategies that will allow you to confidently develop an effective RBM approach in your clinical research program.

  • A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.