Services for Sponsors

ClinicAid is a full service Phase I-IV research consortium specialized in providing overall management and research administration for cancer (oncology) clinical trials [see more]. These services include protocol development, management of investigators and research coodinator teams, clinical and medical monitoring, data management, statistics, and report writing.

Pharmaceutical Outsourcing
Drug development costs have soared in the past ten years driving pharmaceutical companies to look for smarter ways of conducting clinical research. The Food Drug Administration (FDA) estimates that it takes approximately 15 years to study and test a new drug before it can be approved for the general public. This estimate includes clinical trials using human subjects through the FDA approval process. The clinical stage is the most time-consuming and expensive part of the drug development process. Over the past decade, driven by mounting market pressures, companies are increasingly outsourcing clinical trials to reduce costs and time-to-market pressures and increase revenues. Outsourcing by pharmaceutical and biotechnology companies has increased dramatically since the early 1990s. It is estimated that by 2007 nearly 60-70% of all pharmaceutical drug development expenditures will be committed to outsourcing, as compared with 4% in the early-1990s. The immediate benefits of outsourcing drug development results in getting new compounds to market 30% sooner, which, depending on the market value of the drug, can translate into hundreds of thousands of dollars in additional revenue. In fact, the pharmaceutical outsourcing market size is estimated at $10 billion yearly and is expected to grow at 14-16% per year for the next decade. Drug development companies are finding that by using outsourcing strategically, and by effectively integrating external resources with internal capabilities, they can reap large dividends by getting better products to market faster.

Clinical trials focus on developing new strategies for the prevention, detection, treatment, and overall improvement of the care and quality of life of people with various diseases/disorders. Planning, coordinating, organizing, developing, and running a clinical trial can be a difficult, time-consuming, and expensive task. During the last 20 years, the complexity of conducting clinical trials has grown remarkably. Not only has the average number of trials per New Drug Application increased from 30 to more than 85, but the number of patients in a typical submission has also increased substantially. Improving the pace of clinical trials translates into considerable cost savings for drug developers. In addition, more efficient clinical trials would get therapeutic drugs through the research pipeline and into physicians' and patients' hands much more quickly. Investigators have grown increasingly discouraged managing clinical trials due to inefficiencies and large overhead costs. While Contract Research Organizations (CROs) have helped drive efficiencies with Sponsors, little has been done to drive efficiencies at individual research centers. The efficiency of a clinical trial is greatly compromised by several factors including:

• Inadequately trained research teams
  
• Low patient accrual
  
• Significant deficiencies in collecting study payments
  
• Poor understanding of the budgeting process
  
• Substandard quality assurance/control
  
• Lack of formalized/standard operating procedures
  
• Extensive delays in contract negotiations
  

ClinicAid Oncology Research Consortium
Research Consortiums like ClinicAid are CRO service companies geared to individual investigators as well as large research centers that organize and manage multi-site clinical trials without additional costs to the Sponsor. Research Consortiums can leverage scale to provide drug development companies and CROs with principal investigators and research staff (e.g. regulatory specialists, clinical research coordinators, patient recruitment coordinators) to enable clinical research coordination and monitoring of Phase I-IV clinical trials in a cost-efficient manner.

ClinicAid Research Management Inc. collaborates with physicians and scientists to improve disease management in Oncology and Hematology through novel therapeutic opportunities.

Specializing in phase I-IV clinical trials, ClinicAid alleviates the costs of integrating a research program by providing expert project and site management, developing clinical enterprise solutions to improve data collection and accuracy, and delivering professional administrative services to ensure efficient and accurate study objectives. ClinicAid's Investigator-CRO services are customized to support, rapidly facilitate, and improve the management, quality, and economic drivers of clinical trials conducted in human subjects at academic centers and private practice.

ClinicAid seeks to provide expert project and site management, develop electronic systems to improve data collection and accuracy, and provide professional administrative services (finance, operational management, contract negotiation, marketing and branding, recruitment strategies, regulatory affairs, business development) to ensure efficient, accurate, and successful study objectives.

The ClinicAid Difference
We are not a Site Maintenance/Management Organization (SMO) or just a CRO providing operational services to a Sponsor, rather we are a full service Research Consortium where a Sponsor can go to one organization to run a complete clinical program from start to finish while achieving cost savings and higher quality.

ClinicAid's product is its proven formula for delivering successful research programs. Implicit in this strategy are the following core competencies of ClinicAid:

• Centralized and rapid contract and budget review and development
  
• Use of central IRB networks to minimize approval timelines
  
• Development of patient-data bases, strategic recruitment plans, and brand management to drive awareness of research opportunities for patients, investigators, and sponsors
  
• A unified electronic Clinical Management System to enhance simultaneous data collection and management, regulatory management, and scheduling of patient visits and procedures
  
• Guaranteed rapid study reimbursement through web-based finance and collection/receivable systems
  
• Scientific writing to support investigator-initiated studies and improve standardization of operating procedures
  
• Data management and statistical analysis of large and small data sets
  
• Identification of qualified research teams and training support to advance skills and knowledge
  
• Quality assurance and risk mitigation analysis and programs
  

The benefits of using a research consortium like ClinicAid are:

• Increased speed and quality in clinical trial completion
  
• Large network of investigator sites that is scalable and reproducible depending on program needs
  
• Central management and coordination
  
• Large coordinated recruitment plans
  
• Business development, budget management, quality assurance, and problem-solving
  
• Site ownership that is based on varying business models: owned-site model, an affiliated-site model, or a hybrid model
  
• Management of single or multiple specialty organizations
  
• Investigators that are excited, not discouraged, to be involved in clinical research