Services: CROs and AROs

To meet the unique needs of “sponsor” pharmaceutical, biotechnology, medical devices and genomics companies, as well as CROs and AROs that assist sponsor companies in drug development activities, The Helios Group offers the following services:

Business Planning

• The genesis, design and continuing assessment of R&D forecasts, budgets and bids are complex processes that require expertise and a thorough knowledge of today’s R&D business environment.
  
  
• The Helios Group provides expert advice in business planning, including market sector analyses, drug development cycle planning, product forecasts, budget development and financial metrics analyses.

Portfolio Strategy and Opportunity Charting

• Helios assesses the client’s existing opportunities and assists in optimizing its strategy. We assist in evaluating each client’s selling and value-added propositions, their advantages and their competitive environment.
  
  
• Our consulting services provide the means by which informed business decisions can be made through independent evaluation of existing and newly created opportunities.
  
  
• We create targeting strategies in addition to business development plans.

Outsourcing Selection

• In order to expedite drug development and meet "must do" deadlines with limited resources, many firms have been compelled to outsource R&D services. The Helios Group assists in the formulation of outsourcing process, qualification and selection of the vendors, and preparation of request for proposals and analysis of those responses.

Request for Proposal (RFP) Development and Improvement

• Helios Group designs the RFP tool as well as the related processes to provide flexibility and standardized completion, review and comparison.
   
  
• Create and apply budget models

Negotiation Assistance

• Once a bid has been received and the business analysis has been completed, the financial and legal negotiation process begins.
  
  
• We handle difficult discussions in a manner that results in cost-effective solutions while building and maintaining successful long-term business relationships.
  
  
• Types of agreements that we negotiate and/or create:
• Master Service Agreements
• Preferred Vendor Agreements
• Clinical Study Agreements
• Work Orders
• Change Orders

Contract Oversight and Management

• Helios assists not only in the development and execution of the contract but also in the management and oversight necessary for well-executed projects.
  
  
• We often ask to provide Issue Resolution services to both Sponsor as well as Vendor companies.

Project Management

• Every project has its uniqueness and complexities, as does the management process that guides and controls those activities.
  
  
• Helios utilizes experienced project management skills and technologies to minimize the disruption of routine business practices by placing under a single command all the skills, technologies and resources that result in quality, cost effective and on-time deliverables.

Change Management

• With technology and business methods constantly changing, companies must continue with their vigilant efforts to maintain and/or increase their effectiveness and presence.
  
  
• Helios aids in the re-engineering and deployment of new processes and infrastructure as well as assists with modifications of existing systems and groups via the use of best practices methodologies.
  
  
• We develop Standard Operating Procedures (SOPs), manuals and procedures.
  
  
• In addition, we train staff in several areas, including but not limited to,
• Sourcing
• Business operations
• Negotiations
• Project Management
• Change Management