Pricing & Contracting

Sales & Marketing

Quality & Compliance

Research & Development

RESEARCH & DEVELOPMENT

home > industries > life sciences > research & development

With cost-cutting initiatives slashing into research and development budgets, pharmaceutical firms need to get drugs and biologic products to market more quickly and more cheaply. R&D organizations are under pressure to improve productivity, especially with many companies struggling to fill the looming revenue gap as the patents on existing blockbuster drugs expire. Capitalizing on information technology offers one avenue for increasing efficiency within the drug development process.

Our research and development solutions encompass:

Regulatory submissions for pharmaceutical, biotechnology, and medical device firms contain a myriad of documents and data representing years of research. Widespread adoption of the electronic common technical document (eCTD) offers opportunities to improve efficiency and compliance while moving submissions through the development and review process. By managing the entire submission process electronically, team members can develop, control and track submission components, responsibilities, and deadlines in one central location.

Our experts provide best of breed approaches to implementing leading submission management solutions that encompass the full content lifecycle – from authoring to review and approval – with taxonomy standardization based on the DIA EDM Reference Model. These solutions offer version and access control to improve compliance and security as well as traditional document management functionality to improve archive, search, and storage capabilities. They also integrate with common publishing solutions to ensure that the submission process is as seamless at the end as at the beginning, whether your technology platform of choice is Documentum, SharePoint, or another software package.

Ineffective document management can cause unnecessary delays in the drug development process that affect overall time to market. Document control is essential to ensure data is not lost and can be tracked, retrieved, and revised easily, as well as to prove compliance with FDA regulations throughout the preclinical, clinical, and commercialization processes.

Our SMEs have years of experience implementing document management solutions that reduce cycle time by governing and automating the authoring, review, and approval processes for controlled content, such as standard operating procedures, specifications, test methods, and MPBRs. The leading document management platforms also facilitate search and retrieval of documents, version control, and collaboration and integrate with learning management systems to track compliance.

Many studies’ Trial Master Files (TMF) are still based completely or partially on paper, with documentation spread across multiple locations with varying degrees of security and significant duplication. This problem is exacerbated whenever studies are contracted out to contract research organizations. Switching to electronic files improves review, audit, and reporting capabilities, strengthens business continuity and security, and allows for drill-down search through metadata and indexing.

We have extensive experience implementing eTMF solutions that incorporate a collaborative portal for sponsors, CROs, and investigators along with a centrally managed environment for content creation, approval and distribution. These platforms use standardized taxonomy based on the DIA TMF Reference Model and easily integrate with leading submission management platforms.

As partnerships and joint ventures proliferate in the research and development space, managing information across multiple organizations presents an increasing operational challenge. Existing systems often present a limited view of data, making it difficult to accurately track performance and status throughout the project.

Our experts create a collaborative platform to allow joint ventures and partners to monitor and share information. The clinical portal correlates, summarizes, and presents study information with graphical tools and drill-down capabilities. It also provides dashboards with key performance indicators to illustrate the status of critical data, such as site document compliance, patient enrollment, and client satisfaction.

The contract lifecycle is rife with laborious, paper-based processes for contracts and agreements that are susceptible to mistakes and inconsistencies. Mismanagement of contracts can increase legal and regulatory risk and cost a pharmaceutical firm millions of dollars in missed opportunities and extra fees.

Our consultants use workflows and document management capabilities to automate the contract lifecycle, thus reducing the cost and time associated with reviewing and approving contracts. Capturing historical and current data in a single platform also improves visibility into the contracting process, strengthens compliance with corporate policy, and enables reporting and contract analytics.

Clinical trials are becoming a bottleneck to getting products to market as regulators require more data to ensure they are safe for patients. These increased requirements will exacerbate current issues with inefficient processes, poor performing sites, and lengthy clinical study report generation processes that currently cause around 80% of clinical trials to miss their planned completion date.

To accelerate the clinical trial process, we set up controls and predictors for critical trial milestones that can reduce variability for our clients. We also align clinical enterprise architecture with business goals and drivers, incorporating CDISC standards, business process management, service-oriented architecture, portal technology, and business intelligence. Finally, our experts develop clinical data dashboards that integrate different source information to provide a coherent structure for analysis and reporting around enrollment/site tracking, protocol compliance, and data tracking of IND to NDA performance.

Clinical trial management is becoming more challenging with changing government regulations, the need for a global perspective, and tighter resource constraints. Pharmaceutical firms need to reduce risk by improving information gathering, increase accuracy and timeliness of clinical and operational data to support decision-making, and integrate data for disparate systems to increase visibility.

Our clinical operations business intelligence solution encompasses critical processes from clinical research and development through product launch and post-marketing surveillance. It permits direct access to vital operational indicators to allow for monitoring of clinical outcomes and protocol compliance and presents data intuitively in an executive dashboard with drill-down capabilities. This ensures that your strategic, operational, and tactical decisions are based on the best information available, regardless of its source.