Compliance
PRODUCTS
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Drive your program forward with an experienced partner ready to execute early-phase clinical research with exceptional speed and scientific rigor.
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Implement Software Solutions that Support and Enhance Your Mission
Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.
As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.
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Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.
They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.
Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.
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Eurofins PSS Insourcing Solutions is a strategic, compliant, and stable alternative to traditional staffing models, enabling biotech, pharmaceutical, and CDMO organizations to meet operational demands without increasing internal headcount or exposing themselves to co-employment risk. As a managed service provider, PSS hires, trains, and manages scientific personnel who perform defined scopes of work directly at client sites—fully integrated into client operations yet fully employed by Eurofins.
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Identify & engage healthcare professionals (HCP) treating eligible patients—in near real-time
Timely physician engagement is critical to therapy adoption. Quest Diagnostics combines near real-time lab data with other data sources including EHR, claims and prescription data to help pharmaceutical teams identify and connect with physicians managing eligible patients at key decision time point in the patient journey.
In today’s competitive pharmaceutical landscape, ensuring that physicians receive timely, relevant information about new therapies is essential. Quest’s unique combination of industry-leading deidentified lab data, enhanced with claims, prescription (Rx), and EHR insights, allows pharma teams to refine targeting, optimize engagement, and drive better patient outcomes.
WHITE PAPERS AND CASE STUDIES
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LP Execution: Train, Test, Comply An LP (loss prevention) training, testing, and compliance monitoring solution helped $2.2 billion Pep Boys reduce shrink by as much as 10% and cut DC accidents by 50%. Used with permission from Integrated Solutions For Retailers magazine
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Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
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Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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Electronic Informed Consent: Considerations For Implementation In Clinical Trials
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
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Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors
Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.
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Preparing For Post-Market Clinical Follow-Up Under EU MDR
Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.
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PCI Compliance: Xirrus Releases Wi-Fi And Payment Card Industry (PCI) Compliance Whitepaper And Tools Xirrus, Inc., the only provider of high-performance, long-range Wi-Fi products, announced recently the availability of a new tool and whitepaper explaining the PCI (Payment Card Industry) Data Security Standard for companies that use Wi-Fi and handle payment card information.
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Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine
As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.
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Operationalizing Disclosure Intelligence For Go-To-Market Success
Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.
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Safety First In The Field!
Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.
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A Survival Guide To Temperature Data In Life Sciences
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
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GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
NEWS
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MangoApps Adds AI-Powered Scheduling & Shift Swap To Its Extensive Workplace Operations App Marketplace7/15/2025
MangoApps today announced powerful new enhancements to its workplace operations platform, introducing AI-powered scheduling and intelligent shift swap capabilities.
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Recipharm Expands Aseptic Filling Capabilities For Process Development, Pilot Scale And Clinical Supply2/5/2025
Recipharm, a leading global contract development and manufacturing organisation (CDMO), has announced that a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany.
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Paylocity Advances One Unified HCM And Finance Platform With Launch Of Integrated Spend Management Solution7/22/2025
Paylocity, a leading provider of cloud-based HR, payroll and spend management solutions, today announced the launch of Paylocity for Finance, a strategic expansion of its modern workforce platform into the Office of the CFO.
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Curia Invests $4M To Enhance Sterile API Manufacturing10/27/2025
Curia, a leading global research, development and manufacturing organization, today announced the completion of a $4M investment to upgrade its two API aseptic suites in Valladolid, Spain.