A rapidly growing pre-commercialization biotech company has outpaced its ability to demonstrate effective quality oversight of its GCP activities. It needs a detailed review of its Clinical organization and Quality Management System including core processes, technology, and organizational structure. It specifically needs to review its capabilities in the face of ICH E6 R2 requirements for risk-based methods.

A biotech company has just received its first commercial product approval. Anticipating an inspection, new leader of its Pharmacovigilance organization needs a quick and comprehensive assessment of current gaps, potential risks and ideas for tool improvements. Given that operational activities are largely outsourced to a vendor, its ability to demonstrate oversight of vendor activities is a critical to its inspection readiness under ICH E6 R2.

A fast-growing biopharma company has just been granted approval for its first commercial product. Most of the client’s team has never experienced a full non-GMP inspection.  They completed a gap assessment and are actively addressing findings. But the entire organization needs training and guidance on hosting the Health Authority and presenting itself as organized, competent and capable of answering any question that may arise with speed and professional calm.

A mid-sized biotech company was focused on executing a global clinical pipeline but, like many emerging companies, had inefficient and disjointed processes. In addition, processes and teams were not fully grounded in GCP or other regulatory compliance needs. These challenges combined to make the development process cumbersome, inefficient and open to compliance risks.

A small, rapidly growing Biotech had several therapeutic assets moving to clinical development.  It faced challenges in strategic development decisions, CRO negotiations, and senior management information reporting. It needed a consistent means by which to manage and report, and to focus on the science without being encumbered by complicated tools. Timing was critical as some team members would soon be on leave and the company had yet to achieve its first approval.

A mid-sized biopharma company needed to identify internal activities that should be outsourced and implement an objective, defendable process to select preferred vendors that not only fit specific functional/study needs, but also represent best value for investment.

An emerging biopharma company had an inefficient and disjointed process for the selection of vendors to support study-specific activities, from service need identification through contract execution. They had difficulty aligning on needs and during the bidding process, leading to challenging bid comparisons and an over-reliance on Start-Up Agreements (SUAs)

A small biotech company did not have internal resources or capabilities to support Procurement and Clinical Vendor Management functions; the internal team was focused primarily on Study Design and Clinical Operations execution. These gaps in key business functions, coupled with a rapidly expanding portfolio, presented significant risks to timelines and the ability to manage critical vendor activities.

A rapidly growing pre-commercial biotech company found it increasingly difficult to manage large-scale clinical trials being executed by two costly global CROs. The company needed a robust oversight process to handle the rapidly increasing volume of planned trials, since consistent processes, metrics and tool to ensure on-time and high-quality delivery did not exist.

A rapidly-growing EU-based biotech company purchased a US-based entity. The company needed assistance planning and leading integration activities to harmonize across all Development functions.  Some of the capabilities between the two entities were complementary, but they were interested in rapid integration globally, to align with their newly-developed strategy.

A small growing Biotech was bringing its therapeutic assets to full clinical development.  Balancing the need to move through clinical development in a safe but agile manner while guarding the company’s assets and leveraging emerging relationships with strategic suppliers was proving a difficult balance, particularly as different stakeholders had distinct needs and perspectives.  The result was a protracted contracting process which generated confusion and slowed work progress.  All of this while ensuring suppliers met quality and compliance standards to ensure the validity of clinical results.

A biotech company with products in early clinical phases sought to reduce its spend with a large Contract Research Organization, while looking for options to replace with a lower-cost and more responsive CRO. The internal team has limited experience interacting with CROs and needs guidance to ensure a successful trial outcome.

A small biopharma company was expecting a large Change Order (CO) from it’s primary CRO on a Phase IIB global clinical program that was experiencing delays. The company had limited means by which to evaluate the CO, given a mix of performance issues and COVID-related delays in study start-up and recruitment, as well as cost overruns due to low initial estimates for investigator pass-through grants. 

A global genomics data company is building out its core processes and go to market strategy. It must recognize and integrate key quality principles to reduce operational and compliance risk. It conducts its operations in Europe, Asia and North America and is subject to Data Privacy regulations across all jurisdictions. The goal is to make its processes robust and compliant everywhere it does business.

Leading biotech customer with a growing pipeline, relying more heavily on outsourcing partners, needs a way to effectively manage and control portfolio spend and obtain clarity related to study level financials to inform business decisions.