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TikaStudies

TikaStudies for Investigator-Initiated Studies

Investigator studies, sponsored evidence, and research collaborations in one Medical Affairs portfolio.

TikaStudies is how Medical Affairs governs an investigator-initiated study beside the rest of its evidence work. The investigator request, the company-sponsored program, and the research collaboration sit in one portfolio, each tied to the principal investigator, the institution, the milestones, the documents, and the spend.

It is the oversight record. It is not a clinical trial system, an electronic case report form, or a regulatory submission tool.

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Three study types, one portfolio

A Medical Affairs team can turn on only the books it uses.

Investigator study with principal investigator and milestones

Investigator studies

Investigator-initiated requests and contracts, with the protocol, the principal investigator, the institution, the milestones, and the spend on the study.

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Sponsored studies

Company-sponsored non-interventional programs and real-world evidence, governed in the same portfolio.

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Research collaborations

Scientific partnerships that are neither a grant nor a full sponsored protocol. Methods, data, and technical work that otherwise stays in email.

Event lifecycle view v2-1

The study, from request to outcome

The portfolio shows which studies are in flight, on track, at risk, overdue, due soon, or completed. A count opens the list behind it.

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Milestones and deliverables

Planned and actual dates, enrollment targets, payment amounts, checklists, and dependencies. A pace alert shows when a date is slipping.

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People and accounts

The principal investigator is the HCP already on the field record. The study also appears on the institution’s account.

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Who sees it

Therapeutic-area and regional teams see their own studies. They do not inherit the whole company’s book.

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Regulatory dates and outcomes

IRB approvals and renewals, the ClinicalTrials.gov identifier, amendments, risks, and the publications that come out of the work. TikaStudies stores the identifier. It does not submit the registry record.

Word keeps the protocol. TikaStudies keeps the decision.

The protocol stays a Word document. TikaStudies owns the study, the reviewers, and what was decided.

Microsoft 365 is required to open Word Online. A customer can later point the same workflow at a SharePoint site in their own tenant after IT grants access.

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Edit in Word

Open the .docx in Word Online, with comments, track changes, and more than one reviewer in the file.

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A folder per study

The file sits in an organization SharePoint library, one folder per study. It is not on a public link.

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Medical, Legal, and Compliance

Those reviewers work in the same document. Approve, reject, the reviewer name, and the reason are stored on the study in TikaStudies.

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Frozen after approval

Once the final approval configured for that study is recorded, editing of the Word protocol is turned off. The approved file and the decision stay on the record.

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A committee pack

Select several studies and download their current documents together for a review meeting.

Speaker Bureau and Onboarding
Invoicing and Payments-1
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Spend, suppliers, and the field

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Budget on the study

Contract value, payments tied to milestones, suppliers, invoices, and a budget summary live on the study record.

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Field interactions

A scientific conversation about the study can be logged against it, so the relationship and the milestone are not in two systems.

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Publications

Amendments, risks, and the papers that result stay connected to the study that produced them.

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What to evaluate in an evidence portfolio

Medical Affairs evidence oversight fails when the protocol, the investigator, and the milestone live in different files.

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Investigator-initiated studies, sponsored evidence, and research collaborations can sit in one portfolio, and unused books can be turned off.

02

The principal investigator is the HCP record the field already uses, and the study shows on the account.

03

Milestones have planned and actual dates, and a slipping date is visible before it is overdue.

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The protocol is reviewed in Word, and the approve or reject decision is stored on the study.

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The approved protocol can be frozen.

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Spend and milestone payments are on the study, not in a side workbook.

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Therapeutic-area teams see their own studies.

Ask a vendor to open one investigator-initiated study

Show the protocol, the principal investigator, the next milestone, and the decision log without leaving the record.

Questions teams ask before they choose

TikaStudies

What is an investigator-initiated study?

An investigator-initiated study is research a physician or institution proposes and leads, with the company supporting it under a contract. Medical Affairs usually owns the request, the contract, the milestones, and the oversight. TikaStudies keeps that study in the same portfolio as sponsored evidence and research collaborations.

What does TikaStudies cover?

Three books: investigator studies, company-sponsored non-interventional and real-world evidence programs, and research collaborations. Each book can be turned on or off. The record holds the protocol, the principal investigator, the institution, milestones, documents, spend, and the review decision.

Is TikaStudies a clinical trial system?

No. TikaStudies is a Medical Affairs portfolio for oversight of studies the medical team governs. It does not capture case-report data, run a trial, or prepare a regulatory submission.

How does protocol review work?

The protocol stays a Word file. Reviewers from Medical, Legal, and Compliance comment in Word Online. Approve or reject, with the reviewer’s name and the reason, is stored on the study. After the final approval configured for that study, editing of the file is turned off.

Who can see a study?

Therapeutic-area and regional teams see the studies they own. The principal investigator is linked to the HCP profile, and the study appears on the institution’s account.

What does a customer need from Microsoft?

A Microsoft 365 license is required to open the protocol in Word Online. Files are stored in an organization SharePoint library, one folder per study. The customer can later use a SharePoint site in their own tenant after IT grants access.

See one investigator-initiated study

Bring a request that is still in review. The walkthrough follows that study from the protocol in Word, to the principal investigator on the HCP record, to the next milestone and the spend attached to it.