AIMS Service Category

Nonclinical / Clinical Study Execution Support

Plan the right study and support sponsor-side execution through CROs, vendors,
and trial sites.

AIMS supports clients that conduct studies through CROs and trial sites but need stronger experience in study planning, project management, issue resolution, quality oversight, documentation, and interpretation.

Study Plan RFP PMP Oversight Tracker DB Lock Readiness
Why it matters

Study execution succeeds only when sponsor-side planning and oversight are strong.
CROs and sites perform the work, but the sponsor must manage the study purpose, plan, timeline, quality, issues, documents, and how results will be used for development decisions.

Recommended for companies running studies through CROs or sites
but lacking study planning and management experience.

This category supports clients that need sponsor-side planning, CRO/vendor/site oversight, project management, issue resolution, and study result interpretation aligned with development objectives.

AS IS
  • Study starts from a CRO proposal rather than a development question.
  • Sponsor-side project management and issue resolution depend too heavily on CROs or sites.
  • Endpoints, sampling, and assessment plans are not aligned with development objectives.
  • Study timelines do not match financing, partnering, IND, FIH, or PoC milestones.
  • Operational issues are not interpreted in terms of development impact.
TO BE
  • Study plans are aligned with the development question before execution.
  • Sponsor-side PMP, R&R, oversight, issue escalation, and quality control are established.
  • CRO/vendor/site roles and deliverables are managed from the client perspective.
  • Timeline, data quality, documents, and interpretation are linked to development decisions.
  • Nonclinical and clinical evidence is generated efficiently within the target timeline.

How AIMS supports execution

AIMS is not the physical study-performing organization. AIMS complements the sponsor’s management function so that CRO, vendor, and site execution remains aligned with development objectives.

Study planning

Define study objectives, design elements, RFP, and vendor/site search strategy.

01

CRO/vendor oversight

Manage scope, timeline, deliverables, issues, and communication.

02

Site-level support

Support site execution, CRC tasks, eCRF entry, IRB work, and monitoring response.

03

Result interpretation

Connect study outcomes and issues to development decisions.

04

Service modules

The scope is configured by combining planning, nonclinical study management, clinical trial management, and site-level CRC support.

Nonclinical / Clinical Study Planning

This service develops a study plan that clarifies the development question, study objective, key design elements, vendor/site search scope, and RFP/proposal requirements.

Core question
What question should the study answer, and which CRO, vendor, or site should execute it?
Why this service matters
A study can be operationally feasible yet developmentally weak if the sponsor does not define what evidence the study must generate and how CRO/vendor/site options should be assessed.

What can go wrong
if this is not addressed?

01

Study driven by operational convenience

The study may not answer the key development question.

02

Vendor search is unsystematic

Selection may be based on availability or cost rather than fit.

03

RFP lacks strategic requirements

CRO proposals may not reflect the intended evidence generation purpose.

Multidisciplinary participation

The radial chart shows participating expertise only. RACI roles and contributions are shown in the table.

Study Planning multidisciplinary participation graph
Accountable Responsible Consulted Informed

Role by expertise

RoleExpertiseContribution
AClinical Development

Owns development question, study objective, and planning logic.

RProject Management

Structures RFP, vendor search, timeline, and execution options.

CNonclinical Development

Advises nonclinical model, dose, sampling, and endpoints.

CClinical Pharmacology / MIDD

Advises PK sampling, dose escalation, ER analysis, and modeling needs.

CClinical Operations

Advises CRO/vendor/site feasibility and operational risks.

CRegulatory Strategy

Checks regulatory acceptability of design and documentation.

When clients need this service

Client situationAIMS value
The client does not know which CRO/vendor/site should be approached.Defines search criteria and comparison structure.
A CRO proposal needs sponsor-side review.Assesses whether scope, cost, timing, and design match development objectives.
Study design and execution plan need to be aligned before contracting.Builds study plan and RFP/proposal reflection points.

Workflow

01

Define study question

Clarify the development decision the study must support.

02

Develop planning options

Define design elements, population/model, endpoints, sampling, and data flow.

03

Search vendors/sites

Identify CRO, vendor, or site candidates and evaluation criteria.

04

Review proposals

Compare scope, cost, timeline, experience, and risks.

05

Finalize study plan

Document the selected plan and execution assumptions.

Representative deliverables

Study plan

Development question, design elements, execution assumptions, and timeline.

Study option comparison table

Comparison of design options, feasibility, time, cost, and evidence value.

CRO/vendor/site search summary

Candidate list, capabilities, feasibility, and selection rationale.

RFP or proposal reflection memo

Requirements and comments to align vendor proposals with AIMS planning intent.

Relevant standards by service

AIMS defines the standards and guideline anchors that should be considered for each service, rather than treating them as optional references.

ServiceRelevant standardsHow they are applied
Nonclinical / Clinical Study PlanningICH E6(R3), E8(R1), M3(R2), M10, M12Define study quality, purpose, nonclinical/clinical linkage, bioanalysis, and clinical pharmacology considerations.
Nonclinical Study ManagementICH M3(R2), S6(R1), S7A/S7B, S9, S11, S12, M10Manage nonclinical study scope, safety pharmacology, modality-specific evidence, TK/PK, and bioanalysis.
Clinical Trial ManagementICH E6(R3), E8(R1), E3, E9(R1), M10, M12, E14Manage GCP quality, sponsor oversight, documentation, analysis readiness, DDI, bioanalysis, and QT/QTc when applicable.
CRC Staffing at Seoul St. Mary’s HospitalICH E6(R3), E8(R1)Support investigator/site responsibility, source data, documentation, participant protection, and data integrity.

Core terms

CRO

Contract Research Organization that executes study operations under sponsor oversight.

RFP

Request for Proposal used to communicate scope and requirements to CROs or vendors.

PMP

Project Management Plan defining timeline, R&R, communication, issue, and risk management.

DB lock readiness

Status indicating whether data cleaning, queries, deviations, and consistency checks are sufficiently complete for database lock.