Focusing unparalleled expertise on your research challenges
As a single-source provider for clinical trial planning, trial management and drug development planning, 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.
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.
A total solution for better, faster clinical results
Full Service Offering
- Complete oncology clinical trial management and design, including strategic plans for regulatory approval from Phase I through NDA
Preclinical Development
- Preclinical program analysis, design, management and execution
- Preclinical program review and “gap analysis”
Study Design
Study Launch
- Site identification, qualification, management, contracting and payment
- Investigator identification and recruitment
- Oncology patient recruitment and accrual strategies
Study Management
Data Management & Biostatistics
- Data management
- Biostatistics analysis and reporting
- Document preparation and production
- Quality assurance and regulatory compliance
- Medical writing (investigator brochures, protocols, statistical reports, clinical studies, and preparation of documents for regulatory submissions)
Oncology clinical trial management and design, including strategic plans for regulatory approval from Phase I 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.
If desired, our experienced business team can assist you in managing all the financial aspects of clinical trial management.
Preclinical program design, management and execution
Medelis has the capabilities to design and execute your preclinical program, using specialized oncology research models while handling technical writing, laboratory services, toxicology consulting and regulatory submissions.
We work with testing laboratories with the appropriate expertise to perform studies in compliance with Good Laboratory Practices (GLP). Since not all contract labs have the necessary skills, appropriate husbandry facilities or timely availability to accomplish specific studies, Medelis is able to select from several labs that we have prequalified for their expertise. In this way we can offer our clients the most suitable resources to accomplish their tasks. A review of the specific types of preclinical studies available reflects the scope of our interests.
Available preclinical research projects, done in some cases under the guidance of Good Laboratory Practices (GLP):
- Feasibility Studies – exploratory, with several tumor lines
- Proof of Principle – definitive, demonstrative experiments
- Model development
- Novel devices for administration of agents
- Special cell lines – mouse, human, or spontaneous transgenic/mutant tumors
- Route of administration and site
- subcutaneous at defined sites
- in situ
- intravenous
- ascites
- Efficacy of therapy in a defined animal model
- Leukemias
- Solid tumors
- Mammary, bladder, lung, brain, renal, lymphoma, melanoma
- Other, as needed and specified
- Metastases
- Endpoints
- Survival
- Tumor dimensions
- Body weight
- Blood/serum samples
- Terminal organ histology
- Target organ metastases
Medelis works with clients to develop precise animal-based, IACUC-approved protocols. We select the most suitable contract lab to perform the work, and the Medelis team oversees all work, protecting your interests and providing comprehensive, value-added oversight of study execution and interpretation of results.
Submit your preclinical study request for a quote.
Preclinical review and “gap analysis”
If you’ve already created your preclinical plan and would like an independent review, we can provide a “gap analysis” service that delivers an early evaluation of your current preclinical, manufacturing and clinical data, or plans for generating those data.
Medelis can serve as a check of proposed development tasks, resources and timelines, and help to identify developmental bottlenecks and risks. We can also deliver a recommendation on mitigation of those risks, and provide general recommendations on regulatory strategies for global product registrations.
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.
Site identification, qualification, management, contracting and payment
Our extensive contacts in the world’s research community enable us to find the right sites for your trial and help you enroll qualified patients quickly.
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.
Once sites are chosen, Medelis will negotiate budgets and contracts with each site, prepare easy-to-follow payment and reconciliation documents and disburse a client’s funds on its behalf to sites on a timely basis.
Investigator identification and recruitment
Having the right investigators committed to your trial is imperative for getting it into the clinic. First it’s critical to design the trial so it’s attractive to top investigators. Then Medelis can 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
Oncology trials are complex. 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 those hard-to-accrue studies, Medelis can offer individualized and unique internet-based marketing and public relations programs to assist investigators in finding and enrolling patients. Not only can we help to engage other oncology specialists, we can attract the 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. Our services include:
- Case report form design
- Database design and creation
- Data entry
- Data validation
- Medical coding of adverse events and medical histories
- Database lock
- 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
- 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, including:
- Signed and dated protocol signature page
- Completed Form FDA 1572
- Current curriculum vitae of the principal investigator (within 2 years or initialed & dated within 2 years)
- Copy of current medical license for the principal investigator
- IRB approval letter of the protocol and informed consent form
- Current IRB membership roster (within 1 year)
- Financial disclosure form
- Notification or approval of regulatory agencies
- Signed and dated confidential disclosure agreement
- Investigator Agreement (contract/budget) completed and signed
- Completed IRS form W-9
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
- Manuscripts