CrO Biosciences is an information management consulting firm that provides clients with Inspection Readiness, regulatory submission planning and management. We have the expertise necessary to acquire agency approval for regulatory applications in biotechnology, pharmaceutical, and medical device organizations. CrO is a global, woman-owned, operated and controlled company; which consists of regulatory and clinical operations professionals with over 60 years of combined experience. Why settle for working with another company when you can work with the best in the business? Our unique methodologies are up to date with the current rules, regulations, guidances, technologies, and latest industry trends keeping us ahead of the curve every time.
We build the foundation for success by assembling an elite team for every client, every time. We give shape to our clients’ vision through a continuous commitment to quality and delivery. We capitalize on our clients’ talents by blending in complementary strengths to maximize results. We survey the situation, co-design plans, and draw upon our connections to make a difference for those people who are fighting for a longer, better life.
LMK Clinical Research Consulting is a leader in Trial Master File (TMF) document management services. LMK offers comprehensive TMF services specializing in the strategic development, project management and quality control of documents that support clinical development. LMK’s mission is to provide services that maximize quality, compliance, efficiency and inspection-readiness.
Complion’s eRegulatory document and workflow management platform improves efficiency, compliance and transparency for research sites and sponsors. It stores, organizes and routes all regulatory documentation involved in a clinical trial. Complion has garnered overwhelming industry support and has been accessed by more Sponsors and CROs than any other eRegulatory platform.
Just in Time GCP provides clinical compliance consulting and clinical systems management services to support pharma and biotech companies in achieving operational excellence and inspection readiness through all phases of drug development. We have developed an infrastructure that has the capacity to support your organization in managing the oversight and day to day management of your Trial Master Files. Whether you are anticipating a regulatory inspection, need resourcing for routine quality oversight of your TMFs, or are planning the implementation of any clinical system, Just in Time GCP can support you. We have extensive industry experience in clinical operations and truly understand the complexities of trial management and drug development. We partner with your organization in ensuring that your TMFs and other clinical systems are inspection ready. We take the stress out of inspection readiness and TMF management.
Bring Order, Stability, and Control to your TMF Phlexglobal is unique among eTMF providers. We leverage dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.
Montrium is a global leader in electronic content management solutions for the life sciences. By centralizing clinical records in the cloud, Montrium eTMF Connect enables sponsors and CROs to streamline study activities while maintaining inspection readiness. As a dedicated technology partner, we provide a best-in-class customer experience with our deep understanding of the clinical research arena.
Study teams worldwide are adapting to rapid change with centralized and remote processes. Since TransPerfect created the Trial Interactive eClinical platform, it has been our mission to straighten the path for product approvals with paperless, remote solutions. With thousands of active studies and millions of documents processed, Trial Interactive has become the preferred platform for Sponsors, CROs, and Sites around the world. When your document processes and data across the study life cycle are in one place, your operations become flexible, efficient, and cost-effective. Collaborate with team members and organizations for all documentation, review, and oversight with Trial Interactive. The 21 CFR part 11 compliant platform delivers an author-to-archive experience that simplifies and automates essential processes. That means comprehensive solutions for clinical document management, site selection, site activation, learning management, eISF, compliance training, quality, and more, that connect seamlessly with your eTMF for easy indexing. Trial Interactive places key processes in the palm of your hands with mobile content management, eTMF, and site monitoring solutions for document scanning, coding, and CRA reconciliation. Get the information you need in one click to manage your study with our mobile-first CTMS. Additionally, TMF services complement the platform, allowing teams to scale resources and access TMF subject matter experts to establish best practices. When choosing an eClinical partner, you want peace of mind. In clinical product development, that means passing inspections by reducing compliance risks. For over a decade, Sponsors and CROs powered by Trial Interactive have passed inspections and delivered new therapies to patients. Additionally, we have enabled faster timelines, leaving more time to assure quality, completeness, and overall excellence. With Trial Interactive, you can be up and running in weeks, alleviating the pain of complex implementations while affording time for your important work. Our support continues when you go live. We provide dedicated project managers, a 24/7, global, multilingual service desk, and on-demand expertise for needs that emerge during your clinical trial. As part of our community, it is our mission to make sure you are heard. We maintain a transparent platform roadmap and many ways to communicate your pain points and feedback, so you can share ideas to improve the platform and see your requests come to life. If you want to become a more influential contributor to the future of eClinical technology, you can join our customer engagement program. Straighten your path to product approvals. From author-to-archive, we know how.
Bloqcube™ is an integrated Clinical Trials Management and Financial System (CTMFS) for drug development, whose distributed ledger and Cloud based EDC – including an inbuilt eTMF- gives Clinical Development and Healthcare professionals, speedier trials and delivers real time immutable data. We are a transformative company that has built an innovative software solution for clinical trials management. Contact us at: [email protected]