Web Content Management

WHITE PAPERS AND CASE STUDIES

• Large PMA Study Of CRC Diagnostic

  A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.

• BV Dairy Unleashes Growth With Epicor ERP And DocStar

  Founded in 1958 as a family farm in England’s West Country, BV Dairy is now a thriving modern business. Each year, the company purchases 35 million liters of milk from dairy farms within a 25-mile radius of their production facility in Shaftesbury, Dorset and turns them into dairy products for food distribution and manufacturing firms. BV Dairy’s range includes their award-winning Dorset clotted cream, as well as yogurts, buttermilk, soft cheese, and mascarpone.

• How A CRO-EDC Partnership Got Results For Study Sponsors

  To deliver consistent results and ultimately create lasting relationships with sponsors, ARA needed fast and flexible eClinical tools. Medrio offered the ability to set up studies easily, collect data accurately, and make mid-study changes without study downtime saves their clients time and money - and increases the likelihood of repeat business and referrals.

• Standardizing Principal Investigation Delegation Records: An Alternative Approach For Sites

  In 2008 the US Food and Drug Administration (FDA) published Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects. The guidance document is specifically intended to clarify the FDA’s expectations concerning the responsibilities of clinical research investigators and sponsors regarding the supervision of clinical studies in which some study tasks are delegated to investigator employees, colleagues, or third parties. This article to briefly examine these responsibilities, with a specific focus on the delegation of authority, and to present methods clinical research organizations (CRO) can implement to effectively document the delegation of those responsibilities in compliance with FDA guidelines.

• Capabilities For Clinical Studies In Contraception

  Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.

• Altus Research Maximizes Efficiency With eSource

  By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.

• Enrollment Surpasses Projections In International Psoriasis Studies

  A leading global pharmaceutical company selected IQVIA Biotech to support four international Phase III biologic studies in moderate to severe psoriasis. This team was selected because of a proven patient recruitment process with a record of enrollment that could save the sponsor time and money. Successful patient recruitment strategies in 13 countries, where some are unfamiliar with advertising, surpassed enrollment projections.

• Taking Social Services Digital

  County Department of Social Services — operating with a paper-based system for benefits applications and record keeping — finds itself overwhelmed by document volumes and logistical issues.

• eRegulatory Experiences From A Site Without Binders

  A clinical research facility had growing collection of bulky regulatory binders that was crowding them out of office space. Choosing a document management solution was easy. Read how they overcame the challenges of actually implementing the solution.

• How To Avoid Last Minute CMC Roadblocks To Approval

  Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

• Expanded Access For Delivery Of Treatment To Patients With Acute Adenovirus Infections Through A Named Patient Program

  For sponsors, there are numerous operational logistics and regulatory approvals required in order to provide access to their medications through an EAP or CUP. In this case study, UBC deploys a global Expanded Access Program (EAP) to ease the burden on the sponsor and rapidly provide treatment to patients.

• Five Essential Considerations for Efficient Clinical Trial Site Contracts and Payments

  Insights on how to avoid startup delays, issues executing the clinical trial, or problems with making payments to sites.