Services
 



  Services
Strategic Planning
Regulatory
Clinical Trial Management
Information Systems
Business Development

MediVector, Inc. was founded in response to the specific needs of emerging biopharmaceutical companies that are seeking help in the difficult path from bench to bedside.

MediVector has the resources to act as a surrogate medical department. Our goal is to help avoid costly mistakes, to provide and implement a market-oriented strategic clinical development plan, more cost efficiently and with higher quality than other firms can achieve.

MediVector combines its experience in drug development and its proprietary data management and reporting system with its client's expertise in its field of research. MediVector develops an integrated strategic plan which includes understanding the science behind its client's drug, how it can be applied in the clinic, what the efficacy endpoints should be, what safety issues there may be, how to design the preclinical and early clinical trials, and what our client's options are regarding the clinical development pathway. With this understanding, MediVector designs a database which, when used with our proprietary web-based data entry and reporting system, will provide real-time information on the progress of trials. Clients can then make strategic decisions at the earliest possible moment, which may enable savings of millions of dollars and years of drug development time.

Our experienced team includes experts in regulatory, manufacturing, strategic clinical planning and trial management, statistics, business development, legal and financing issues, and information systems for biotechnology companies. MediVector gives you access to a large "as needed" staff of sophisticated experts, whom you may not need full-time but whose advice may be invaluable. These experts have been added to the MediVector team based on their experience and successes in the same areas that you are entering, and help you save time and money by avoiding mistakes or blind alleys in the developmental process.

MediVector has developed a user friendly web-based entry and reporting system which enables it to provide cleaner data at lower costs. This system does away with the need for data entry and coding personnel, decreases the number of trips to the site by the clinical research associates (CRAs), and is formatted to be submitted directly to FDA as a Computer Assisted NDA (CANDA) or PLA (CAPLA). MediVector has demonstrated that this approach can cut clinical trial time and monitoring costs by up to 30%. Time saved during the conduct of clinical trials, plus the decrease in review time that results from the submission of a CANDA or CAPLA, can enable clients to reach the market at the earliest possible time, and achieve profitability sooner.

As a partner throughout the drug development cycle, MediVector takes a broad view of its tasks. For example, taking a long-term view of the clinical goals at the beginning of drug development enables MediVector to provide a customized database which clients are able to use throughout the development of this drug. This saves the usual fee charged per trial of setting up the database.


MediVector's Services Include:

 
 
Strategic Planning:
  MediVector uses a team approach to formulate an integrated development plan and timeline. It clearly identifies the potential clinical markets, approvable endpoints and safety issues of concern, competitive issues, if/then critical decision points, chemistry, CMC, and business development issues.
Regulatory:
  MediVector provides high level regulatory support and prepares pre-IND and IND documents, NDAs and BLAs, and FDA presentations. MediVector can also prepare foreign regulatory submissions.
Clinical Trial Management:
  MediVector provides full service trial management. Using the overall clinical development plan, MediVector creates a customized relational database, remote data entry screens for data entry, automated interim reports, and data listings. MediVector has access to a network of investigators and thought leaders in oncology, immunology, rheumatology, and other therapeutic areas.
Information Systems:
  MediVector can establish local area networks, and can link established networks with the client company's database for as-needed access. MediVector educates the clinical sites about the use of its data entry system, and provides user support.
Business Development:
  Assistance with establishing partnerships and seeking licensing opportunities.


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