All
Brochure, business strategy, commercialization, business plans,
go-to-market strategy, clinical trial strategy, regulatory affairs, radiopharmaceutical support, medical
imaging in clinical trials, data analytics, due diligence, mergers & acquisitions support/advisory,
100-day plans, advisory roles, investor decks, pitch decks, pre-IND preparations & submissions, IND,
NDA, & BLA preparations & submissions, 501(K) Submissions, PMA applications, ODD (Orphan Drug
Designation), FDA Meetings, Critical Path for Innovation Meetings (CPIM), Regulatory gap analysis,
Regulatory strategy, US Agent Services, Interim or Independent Regulatory Services, C-suite services
(all), Strategy & Development, Growth marketing, Branding & Messaging, Content & Media
Production, Digital, Inbound, Account-based or campaign marketing, Media placement, Advertising,
Podcasts, SEO audits & keyword research, website revamping, HubSpot Gold Partner, clinical trial
sponsors, sites, and PI lists, lead research, natural language processors, data mining and curating,
dashboards & visuals, data strategy, clinicaltrials.gov, contract research services, eClinical &
digital health solutions, patient engagement, sales, marketing & data software
Consulting
PDF landscape, business strategy, Commercialization, business plans,
go-to-market strategy, clinical trial strategy, regulatory affairs, radiopharmaceutical support, medical
imaging in clinical trials, data analytics
Consulting
PDF landscape, radiopharma, radiopharmaceuticals, theranostics, key
opinion leaders, subject matter expertise, commercial strategy development, market launches, commercial
due diligence, market validation, competitive analysis, medical affairs support, market access support,
supply chain, logistics, risk mitigation
Consulting
PDF landscape, Clinical imaging, Biomarkers, Medical imaging, Imaging core labs, Imaging experts, Imaging CROs, Imaging endpoints, Imaging charters, Imaging trials, Imaging vendors, Imaging protocols, Imaging data management
Analytics
PDF landscape, clinical trials data, market analysis, account research,
reporting, workflows, quality leads, alerts, CRM, smart advertising and custom content
Analytics
PDF landscape, clinical trials data, market analysis, account research,
reporting, workflows, quality leads, alerts, CRM, smart advertising and custom content
Marketing
Case study, digital health, mission, objectives, capabilities, marketing
strategy, core messaging, key messaging, quality content, white papers, blogs, SME interviews, proactive
advertising management, monitor ad performance, transparent data, informed decision-making,
cross-campaign insights, continuous optimization, increase awareness, address target audience needs,
on-target leads, cost per lead (CPL)
Marketing
Case study, 43 leads in two weeks, digital care solution, targeting
health systems decision-makers, focused messaging, revamped visuals, build audience lists including job
titles, controlled for quality variables, proactive advertising management, transparent data, continuous
optimization, address target audience needs, on-target leads
Regulatory
FDA Meeting Request Checklist, Quick Reference Guide, FDA Meeting
Request Calculator, FDA guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA
Products Guidance for Industry, Draft Guidance, December 2017, The Bracken Group, FDA Meeting Types,
Type A Meeting, Type B Meeting, Type C Meeting, Type D Meeting, INTERACT Meeting, FDA Meeting Timelines,
FDA Meeting Request & Meeting Package Checklist, Application number, Product name, Chemical name,
established name, and/or structure, Proposed regulatory pathway, Proposed indication(s) or context of
product development, Dosage form, route of administration, and dosing regimen, Proposed meeting format,
Proposed meeting dates & times, Proposed agenda, Pediatric study plans, Human factors engineering plan,
Combination product information, Brief statements of the purpose of the meeting, Specific
objectives/expected outcomes from meeting, Proposed questions for FDA, Background Information: History
of the development program, Background Information: Substantive changes in product development plans,
Background Information: Current status of development program, Meeting Attendees, FDA staff or
disciplines to attend meeting, Date that meeting briefing packet will be sent, Data to support
discussion organized by discipline and question
Consulting
Case study, biopharma, clinical trials, Imaging endpoints, imaging core
lab (ICL), imaging CRO, ICL work was inadequate, imaging charter, read design, reader training, team
communications, protocol development, optimizing endpoints, imaging guidance documents
Marketing
4-fold brochure, Strategy & Development, Growth marketing, Branding
& Messaging, Content & Media Production, Digital, Inbound, Account-based or campaign marketing,
Media placement, Advertising, Podcasts, SEO audits & keyword research, website revamping, HubSpot
Gold Partner
Marketing
PDF portrait, Keosys case study, generate new leads, drive consistent
business, increase domain size by creating content, increase site-wide conversion rate, reduce cost per
lead
Marketing
Case study web page, ZEDOC, New Zealand, website traffic, quality leads,
low cost per lead, digital care pathways
Marketing
eBook, client expertise, landing page, input form, lead conversion