Business / Project Strategy

qointa has experience with organized systems and with creative, market driven solutions. You get access to gime's advisory group and leaders will help guide the creation of a successful project/business.

Business / Project Development

qointa supports companies by via focused business/project designs, specific timelines and business/project plans based on business/project requirements and external resources needed by the sponsors to complete a successful project.

Business / Project implementation

qointa provides expert project implementation and management teams that are focused on organized systems of healthcare. Our experience includes database utilization, HIPAA compliance, structuring of resources, integrated operational processes and organizing high patient volume primary care physicians and and other resources.

Consulting services

Consulting services for strategic design of Late Phase Studies & Risk Management Programs

  • Protocol development
  • CRF design
  • Data Analysis Plan & Report development
  • Study start-up activities
  • Development of Study Reference Manuals & other study materials
  • Investigator and Study Coordinator training
  • Medical writing
  • Remote and onsite monitoring
  • Site relationship management
  • Integral support to the multi-tiered call center
  • Liaison with participants and Field Personnel for the study
  • Monitor site and patient enrollment
  • Clarify processes and logistical procedures
  • Respond to questions regarding completion of CRFs, interpretation of data reports, etc.
  • Dissemination of study materials
  • Assist in resolution of data queries
  • Contract personnel

Recruiting & Staffing
 
Custom projects and consulting

We offer a range of clinical and business related services from expert personnel - at a speed and quality that you've never experienced before.

Whether you need assistance, or even just another set of eyes and opinion, gime delivers comprehensive concrete action plans in

  • Regulatory Strategy
  • Clinical Operations
  • Site & Department Audits
  • Technology Implementation
  • Site and Investigator Training
  • Patient Information Materials
  • Contracts and related Negotiations
  • Website/Internet Presence/Promotion
  • Branding, Messaging, Positioning
  • Marketing/Sales Material Development
  • White Paper Authoring
  • PowerPoint/Keynote Presentation Development

(keep in mind marketing is far more than mere promotion, and "tele-marketers" aren't marketers at all!)
.

Regulatory Compliance/Quality Management

Our compliance services include Strategic Compliance services, Tactical services, Service Level Agreement (SLA) based CSV services, and CAPA services. Our extensive experience with IT compliance covers areas governed by US FDA, equivalent international agencies, and other regulatory agencies. Our IT compliance services address GMP, GLP, GCP, QSR, PDMA, HIPAA, SOX, HR privacy, and other applicable regulations. We have a proven track record validating stand-alone, enterprise, and multi site systems used in:

  • regulatory compliance
  • clinical operations
  • laboratory data management
  • manufacturing/distribution operations
  • sales and marketing.

Finding and assessing clinical technology providers

Through a rigorous process we prequalify vendors in...

EDC/eClinical
Monitoring
IVRS
Central IRBs
ePRO
Biostats
QA
Specialist CROs
         ...and many more.