Clinical Claire (Persona)

On time / On track

On Budget

Quality / Operational Excellence

Trial Data Report done on time

Enrollment done on time

Research done as quickly as possible

Trial Delays

Goals / Needs

Problems

Can't afford any gaps in the timeline

Ensuring smooth communication with Sites, Monitors, PMs

Making sure everyone understands and follows the protocols, SOPs and regulations

Recruitment issues (most frequent) - plan not fulfilled.

Seeing the project fail because of timelines (biggest pain), leads to delayed next stage. Avg delay costs of 1m Euro / day.

Technical challenges, lack of efficacy - can we recruit on time?

Ensure all study activities are completed in accordance with health authority regulations, and SOPs.

Ensure operational feasibility of clinical development plans and scenarios, including timeline, budget, and resource requirements.

Keep the clinical program on track, that's what I report on.

get the drug on the market asap, research done as quickly as possible with the level of quality

Vendor Selection

Normally has a vendor pool available (preferred providers shortlist), - especially in more established companies. wouldn't go to other vendors unless the current ones can't fulfil the req. e.g. speciality, rare disease - where only a few studies have been done, they'd look for expertise OR Geography - might be open to involve local providers.

I go for info to my team/former colleagues, tend to prefer good historical relationships.

ISR 2017

1 Operational Excellence

2 Prior positive experiences with services provider

3 Therapeutic Expertise

4 Project Manager Quality

5 Experience with Similar Study Types

6 Global Footprint

7 Easy to work with

8 Patient Recruitment Strategy

Ideal Contractor

Thoughtful, reliable, detail oriented and has great experience in the pharmaceutical sector as a clinical research associate.

Background as a Med tech, data manager and CRA as well as experience working for a fast paced pharmaceutical company

Can deal with diverse challenges and aggressive timelines.

Work very well in a team environment and has consistently developed strong working relationships with study site personnel.

Top-notch clinical operations/research professional, if they says that they will do something, they do it and do it well.

Has a knack of staying on top of extremely detailed project information while presenting the big picture to senior management.

Ability to work on very detailed, cross-functional projects, possibly at different companies.

Positive outlook.

A very good writer, can handle highly technical writing for regulatory submissions and clinical research for several studies

Someone to look them in the eye, tell them what they can or can't do, and then stand by their word

Clinical Leader (2018 article)

Specific therapeutic area and indication experience

Team member experience in the indication

Approach to current challenges (demonstrated understanding of enrollment, feasibility, access to KOLs, and investigative sites with the right population and experience)

Responsiveness and ability to be limber with internal and external processes/systems (don’t forget to conduct a qualification audit as a contingency to an agreement)

Quality/consistency of performance/financial stability/inspection history

Value (determine the best service for best price)

Transparency (confirm the scope of service delineates the client will have access to systems)

Collaboration and communication planning (ask if they have escalation strategies)

How do they plan (ask for examples of schedules, what plans will be part of the service, i.e., project plans, risk management plan, subcontractor management plan, monitoring plan, statistical analysis plan, data and pharmacovigilance plans)

transparency, collaborative partnership, and real-time responsiveness

Other

Dedication / Attention / Priority of the project (large CROs tend to focus on bigger projects and neglect smaller ones.

Flexibility to Sponsors needs - they often feel like they need to fit themselves into the CROs normal practices (especially with larger CROs)

Team Chemistry. More than any other single selection criterion, sponsor companies stressed the importance of a good relationship between the two company teams.

CRO's project management team

Project execution plan

CRO experience. Sponsor companies and CROs placed great weight on a CRO's relevant experience, both in the same indication as the study and in the CRO's overall experience in the appropriate therapeutic area.

Price "...fewer than one in 10 (7%) of the sponsor company respondents considered the lowest price as decisive in selecting a CRO. In contrast, more than a third of the CROs (38%) felt price was a fundamental selection measure for sponsor companies."

Processes for Issue Identification and Resolution

Regulations. (15%) - feel constrained by the complexity of the guidelines they follow. Additionally, the variations between different regulatory bodies, and the challenges that brings, comes up repeatedly.


As trials are increasingly looking to emerging markets in new countries, there is also the need to understand whole new sets of requirements.

  1. Complexity of Trials (21% of respondents)

Spiralling Costs (15%)

Responsibilities:

Ensuring proper monitoring of the clinical study

Ensuring all the necessary ethic review(s) and approval(s) are obtained

Selecting the investigator(s)

Providing investigator(s) with the necessary information to conduct the clinical trial

Preparing and submitting clinical trial application(s) and amendment(s) to the appropriate regulatory agencies

Ensuring that the clinical study is conducted in accordance with Good Clinical Practice (GCP)

Generating the appropriate clinical trial documentation