Clinical Trials

Take advantage of the vast knowledge of an expert team who manages drug development programs to support hundreds of regulatory submissions each year.  With Early Phase Development Solutions, you seamlessly integrate the complete array of nonclinical services, including lead optimization, safety pharmacology, toxicology, pathology, bioanalytical, drug metabolism and pharmacokinetics, to assure successful design and conduct of your program—all the way through IND/CTA submission and into first in human clinical studies.

With Early Phase Development Solutions, you benefit from the retained knowledge from nonclinical study results to move your compound across drug development phases more effectively. The focus will be on two critical aspects of your FIH studies: scientific integrity and human subject safety. As early research continues to demand more complex studies requiring special populations, multiple endpoints and adaptive protocol designs, you’ll gain the advantage through 35+ years of insights and industry-leading human AME expertise.

Waiting until you have a complete data package before designing your Proof of Concept (PoC) study can waste valuable time. Instead, you’ll enjoy innovative approaches to these shorter, scientifically demanding studies by parallel processing study feasibility and site assessments, incorporating relevant biomarkers and leveraging adaptive trial designs. Increase your clinical ROI by applying the right level of medical, scientific and therapeutic expertise resources and patient stratification strategies to your program.

How is it possible to shave up to 30% on your program?  It’s about streamlining your journey, taking out whitespaces, and rethinking risk-management.

We offer you a deep, experienced team focused on this crucial phase of molecule development. Let us partner with you as you transition into the clinic with an eye toward future phases. An experienced partner gets you results as you introduce your compound in humans and move to proof-of-concept.

Study delays and missed recruitment timelines are far too common. Your main considerations are quality, time and cost. By partnering with Covance, you can rest assured that your drug will stay on track toward the next development milestone. Our processes are specifically designed for early clinical studies. In fact, we have locked over 1,000 databases and met our healthy volunteer and patient enrollments over 90% in the past 5 years.

You only need access to the resources that matter most to your study and you shouldn’t have to deal with a bigger footprint than you need. We understand. That’s why we deliver the right combination of strategy and execution, resources and tools that help you meet your end goals.

You want a team of experts that have a proven track record in your therapeutic area. We deliver recognized thought leaders in early clinical design and execution for a variety of therapeutic indications including oncology, metabolic, neuroscience, cardiovascular, inflammation and infectious disease.

We have the database and site relationships to ensure rapid identification of potential investigators and their patient populations to help ensure enrollment goals are met. We can also train investigators and site staff on protocol requirements, best practices and technology tools, such as electronic data capture (EDC) and safety systems.

Additionally, we can monitor for compliance with the study plan, protocol and IRB review, and control of investigational products, as well as report safety data, inform sites about performance and contractual issues, and serve as a point of contact between site, sponsor, CRO and IRBs.

By utilizing the most appropriate communication channels, dynamic patient education materials, loyalty programs, motivational tips, appreciation items related to the disease and reminders, we attract and retain broad pools of quality, prescreened patients.

Our Global Study Start-Up (GSSU) team quickly identifies and activates qualified, credentialed and motivated sites. Each study has an experienced manager assigned to coordinate and facilitate start-up activities.

Your dedicated GSSU team can manage IRB/EC submissions, conduct informed consent reviews, take care of essential document collection and submission, deploy comprehensive metrics tracking benchmarks against projections, maintain post-start-up documents, manage translation, and coordinate site contracts and budgeting.

The team will monitor critical milestones and make sure that you have oversight of your clinical trial at all times so that you can track its progress.

Our clinical monitoring services include study procedure development, source document review, patient eligibility confirmation, patient compliance tracking, supply inventory management, adverse events reporting, regulatory compliance monitoring and regulatory documentation maintenance.

Let our professional writers help you with regulatory writing, protocols and protocol amendments, informed consent forms/patient information leaflets, clinical study reports, subject narratives, investigator brochures, integrated summaries of safety/efficacy, literature summaries, clinical expert reports, INDs, NDAs, BLAs, CTAs (Module 2) summary documents, IND and NDA annual reports, safety aggregate reports (PSURs, PADERS, line listings, DSURs), and clinical trial registry synopses.

We can guide you on the most appropriate method for data collection to best serve the needs of study sites and project teams. Our data management services include Case Report Form (CRF)/eCRF design; database design and implementation; data validation, review and cleaning; medical coding; data management processes inspected by an independent quality control team; comprehensive management of data from third-party electronic data vendors; data consolidation, migration and conversion, including CDISC SDTM transformations; study rescue services; consultation and data management strategies, systems, procedures and metrics; and flexible staffing.

Our dedicated professionals include PhD and MS-level statisticians and statistical programmers located in North America, Europe and Asia, who adhere to a single set of global standards and manage various regulatory agency requirements. Our functional teams can also use our customers’ standard operating procedures if preferred.

Services include protocol development, including sample size and power calculations; randomization schedules; statistical analysis plans; statistical programming; statistical analyses using current methodologies; interpretation and reporting of data for clinical trial reports and publications; statistical and strategic consulting for product development; interim analysis for early decision making; database integration; adaptive design consulting and simulation support; data monitoring board management and support; NDA-ready data listings; CDISC-compliant datasets; and integrated safety and efficiency summaries.

The breadth of our experience and services provides us with unique insights into the organizational dynamics that influence a late stage initiative. This provides our customers with consensus and clarity, leading to highly effective research programs that often commence well before product approval. Our customers benefit from achieving both commercial and scientific success through a balanced and operationally cost-efficient approach that recognizes the distinct attributes of the post-approval landscape.

-Clinical

Our clinical services include observational (non-interventional) studies and patient registries; comparative effectiveness research; interventional studies; safety surveillance studies; risk management/epidemiology; endpoint studies; compassionate use programs; and label extension studies.

-Humanistic

Our humanistic offering covers patient-reported outcomes research; quality-of-life instrument development and validation; quality-of-life studies; and direct-to-patient registries.

-Economic

In terms of economic services, our Late Phase team has extensive experience in cost-effectiveness studies; economic models; global value dossier development; health technology submissions; meta and database analyses; and pricing and reimbursement support.

All stakeholders want information to understand what works in the real world, beyond the constraints of clinical trials. Observational studies look at outcomes in everyday medical practice, and observational research presents both opportunities and limitations, requiring a firm strategic foundation to determine how it should be constructed.

We provide a wide range of services in order to meet your objectives, including study design (statistical analysis planning and communications planning); overall project management/management of scientific advisory panels; protocol/guidelines development (informed consent, case report forms); site recruitment and management (site agreements, EC/IRB approvals); data management (EDC, EMR, paper, hybrid); quality management (site interaction, data quality monitoring and SDV, safety reporting); and analysis and reporting (presentations, abstracts, manuscripts).

Our semi-annual Survey on Observational Research provides below-the-surface insights into the industry, revealing challenges and best practices, as well as contributing to improving understanding and consistency in this new and important category of research.

Respondents include industry professionals, regulatory agency personnel, providers and academics from more than forty countries.