Download free issues of Peer Perspectives in Oncology:
Adaptive Trial Design in Phase I and II," an interview with Cytel Inc. CEO Ranganath Nayak, Ph.D.
The Lost Opportunity in Phase I Oncology Trials, an interview with Medelis co-founder and Medical Advisory Board Chair Dan Von Hoff, M.D.
Complete Phase IB: Dr. Dan Von Hoff discusses the nuances of "the complete phase Ib," a trial design that streamlines phase I by testing various drug combinations in one trial with multiple arms running in parallel.
Patient Safety in Clinical Trials: Dr. James Gourzis discusses factors that have launched patient safety to the forefront of public scrutiny, including the effects of increased reporting requirements.
The Lost Opportunity in Phase I Oncology Trials, an interview with Medelis co-founder and Medical Advisory Board Chair Dan Von Hoff, M.D.
Preclinical Trials - A Nuanced Approach: Dr. Mike McGarry describes a more nuanced preclinical process that can help a biotech Chief Medical Officer get into the clinic faster.
Focusing unparalleled expertise on your research challenges
As a worldwide single-source provider for phase II clinical trial planning and management, Medelis is helping biotechnology and pharmaceutical companies by delivering the best total solution—and all the support required—to optimize the return on your clinical research investments. And we accomplish that in the quickest, most responsive way possible.
» To learn more about our phase II CRO services, please contact us today.
Specializing in phase I and II oncology trials
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World-class expertise for your drug candidates
Medelis' medical founders, team physicians and clinical trial management physicians are internationally-recognized oncology thought leaders. They organize and chair sessions at national and international oncology meetings and serve as officers and board members of professional oncology organizations, including The American Association for Cancer Research and The American Society of Clinical Oncology.
- Our team has managed phase I, phase II, and phase III trials in the US, Canada and Europe.
- We offer extensive EDC experience including usage in those phase II trials that need to carefully balance costs and reporting speed.
- We've worked with all different sponsor types: public and private, biotech and pharmaceutical, governmental, large and small, European and U.S.
- Our medical monitors are always board-certified oncologists.
- We’ve handled most targets within oncology.
- We also provide full preclinical research services.
In addition, our relationships within the oncology community allow us to bring aboard additional experienced resources if we run across that rare instance requiring a unique expertise.
Our approach is driven by a critical mass of clinical research expertise, the ability to identify and focus on the most significant challenges, and your need for prompt results. Our world-class insight and experience in the development and execution of clinical research plans and protocols delivers the decision support you need to chart your next clinical move.
Trial management and design, including strategic plans for regulatory approval, from Phase I and Phase II through NDA
Medelis can create and implement a detailed drug development plan carefully structured to address all regulatory needs and requirements. We can optimize the likely outcomes for your agent with respect to follow-on studies and additional indications, delivering maximum value for your clinical investment.
Protocol development
Leverage the thought-leadership of Medelis’ Medical Expert Team for your drug development strategy. Our team knows when new agents are coming into clinical development, and we work with our clients to create the best strategy to move treatments through the clinic. Use us as a sounding board, as a resource during FDA conversations, or to develop your entire protocol from scratch.
Phase 2 site assessment, management, contracting and payment
Whether you’re looking for the reputation of an academic institution or the rapid start-up of a private facility, Medelis has the relationships and experience to get the right sites for your trial.
Investigator identification and recruitment
Medelis will leverage our world-class oncology network to quickly find the right investigators to get your trial started and get the answers you need.
Project management and monitoring of clinical studies
All of our project managers and CRAs have deep hands-on oncology trial experience. Knowing the sites, patients and investigators allows us to comfortably manage the risks and opportunities that occur during a Phase I, II or III oncology clinical trial.
Careful management of site visit frequency and time on-site can be very critical to the economics of a study, but this factor has to be balanced at all times to assure the accuracy and completeness of data.
Medical monitoring and management
Medelis also provides drug-safety services to manage the collection and reporting of serious adverse events. We can define the overall procedures for the collection, evaluation, and reporting of SAEs, providing 24 hour assistance and immediate reporting from site to you.
Board-certified clinical oncology specialists are also available to offer medical management and oversight on a client’s behalf, working closely with site investigators and the client’s own experts to assure the greatest safety for patients.
Oncology patient recruitment and accrual
For hard-to-accrue studies, Medelis offers individualized and unique internet-based marketing and public relations programs to assist investigators in finding and enrolling patients. We help engage other oncology specialist and attract patients themselves, improving the speed with which critical data is obtained.
Data management
Medelis uses the latest technologies for electronic data capture, management and communications. Of course we can also use paper-based data collection when appropriate. Data management services include case report form design, database design and creation, data entry, data validation, medical coding of adverse events and medical histories, database lock, and data transfer.
Biostatistics analysis and reporting
Medelis provides a complete array of biostatistics analysis and reporting, including sample size calculations, randomization schemes, study design & protocol development, statistical analysis plans, statistical programming using SAS, data conversion, statistical tables and data listing for clinical study reports (CSRs), statistical reports, statistical consulting, and statistical representation at FDA meetings.
Document preparation and production
Medelis can assist in creating, reviewing and approving all clinical trial documentation, from site-specific informed consent documents to all original regulatory documentation.
Quality assurance and regulatory compliance
Medelis maintains its own corporate Standard Operating Procedures (SOPs) which govern critical trial operations. Our SOPs were designed by and are monitored and updated by team members with deep regulatory expertise. We update our SOPs annually, and also create study-specific SOPs as required.
Medelis also offers regulatory support for both sponsors and investigators to ensure compliance with applicable regulations. We handle all necessary audits, training and submissions to ensure compliance runs smoothly throughout the trial.
Medical writing
Medelis provides comprehensive medical writing services for all points from pre-IND through NDA. We can also provide study-specific services for protocols, INDs and investigator brochures, clinical study reports, regulatory briefing documents, clinical safety & efficacy summaries, abstracts for professional meetings, presentations for FDA and other regulatory meetings, and manuscripts.
» To learn more about our phase 2 CRO services, please contact us today.
