Publication management software for medical writers

64 | September 2020 Medical Writing | Volume 29 Number 3

Jackie RaskindKPS Life, LLC, Malvern, PA, USA

Correspondence to:Jackie Raskind, PharmD57 HaGallil StreetRa’anana, Israel, 4325143+1 (216) [email protected]

AbstractManaging a complex publication plan forseveral products or indications with over -lapping timelines can be challenging.Publication management software solutionsare available to support the medical writer inplanning, writing, approving, and dissem -inating scientific publications. Key features ofthese programs include design and approvalof a publication plan, verification of authoreligibility, assignment of medical writingresources and authors, management of

document reviews, auditing of authorcontributions, and ensuring compliance withindustry standards, transparency require -ments, and standard operating procedures.Some software packages provide data visu -alisation tools to track performance, budgetspent, and author engagement. Medicalwriters supporting publications shouldbecome familiar with software features toimprove efficiency in managing and writingscientific communications.

The pharmaceutical industry is committed topublishing clinical study results,irrespective of whether they arepositive or negative.1 By dis -seminating scientific data, asabstracts, posters, presenta tions, ormanuscripts, pharma ceuticalcompanies meet ethical guide lines,industry standards, and corporatecompliance requirements.2, 3

Publication planningA publication plan is a product-specific strategicdocument that evolves over a product’s lifecycleaccording to the stage of research. It is generallydeveloped and executed by the medical affairsdepartment in collaboration with cross-functional stakeholders. The publication planspecifies how the communication will bedelivered (e.g., poster, manuscript, presentation,or video content), what audience will be targeted(e.g. payer, healthcare provider, patient), what thecontent will be, and what the strategic messageswill be. Key messages may be defined according

to the research conducted, competitoranalysis, or gaps in published

literature. Deciding where topresent research can depend

on the type of researchconducted, the audience tobe targeted, the type ofpublication, and journal

metrics (impact factor,publication lead times, and

rejection rate).4

Publication management software for medical writers

A publicationplan is a product-specific strategic

document that evolvesover a product’s lifecycle

according to the stageof research.

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www.emwa.org Volume 29 Number 3 | Medical Writing September 2020 | 65

In addition to the well-established role of themedical writer in authoring content andmanaging reviews of publications, medicalwriters are often consulted to contribute to thestrategic publication plan. However, managing apublication plan for multiple products orindications with overlapping timelines can bechallenging. An integrated software solution canhelp design, approve, and implement a publi -cation plan, verify author eligibility, assignresources and reviewers, manage documentreviews, audit author contributions, and ensurecompliance with Good Publication Practiceguidelines, transparency requirements, and

standard operating procedures.In this article, I present key features of three

proprietary software solutions designed tosupport company-sponsored publication plans(Table 1).

The PubSTRAT suiteThe PubSTRAT suite (Anju Life Sciences Soft -ware) is an integrated software solution com -prising several web-based applications coveringpublication planning, writing, document man -age ment, and citation. These solutions includeJSCA ( Journal Selector and ConferencesAuthority), SYQUENCE (an information life -

cycle management platform), PubSTRAT(Publication Project Management Application),and Cite Central (a citation and knowledgerepository). These individual platforms may bepurchased separately or as a single integratedsolution.

JSCAJSCA, a journal and conference database thatincludes more than 2,500 journals and 1,500conferences (and 600,000 abstracts), can be usedto design a publication plan. Users can search theplatform by MeSH (Medical Subject Heading)term and can access a list of journals, a citationcount, journal impact factors, Eigenfactor scores,and journal selection criteria. Crucial informa -tion that assists in publication planning includesthe estimated time from submission to accep -tance and time from acceptance to publication.Selection criteria for conference acceptance arealso included and are updated daily as theconference date approaches. Analytic featuresinclude the number of articles published byjournal per topic/MeSH term within a giventimeframe, which can be presented in both intabular and graphical formats. Future updates willinclude an abstract library sourced from theJSCA database.

Raskind – Publication management software for medical writers

Figure 1. Publication plan Gantt chart: SYQUENCE (PubSTRAT)In SYQUENCE, publications by project and type are presented vertically. The timeline for each project is shown horizontally on aGantt chart by quarter, month, and year. The colour coding describes the project status: red indicates pending, orange indicates activeauthoring, and green indicates published. Projects can be filtered by project name or timeframe.

Table 1. Key features of publication management software

Feature PubSTRAT Datavision® PubsHub™Author publication management X X X

Real-time review X X XDocument audit trail and version history X X XConfigurable email templates and notifications X X

Journal and conference database X X XPublication planning software X X

Project wizard X X Configurable timeline templates X X Data visualisation module X X

Publication repository X X XVeeva Vault integration X X X


Publication management software for medical writers – Raskind

SYQUENCEThe SYQUENCE application enables users tocreate the publication plan in an electronicformat and to circulate it for approval by asteering committee or leadership. SYQUENCEcaptures tactics (strategic recommendations) fora study or product, including the focus ofcommunication, the target audience, and keydates and milestones. This allows for publicationtactics to be mapped on a timeline (Figure 1).Once the plan is approved in SYQUENCE, eachtactic is automatically synched with PubSTRATas a separate project.

PubSTRATPubSTRAT integrates publication planning andworkflow management for internal and externalauthors through a cloud-based application.System access can be configured by user type(e.g., project manager, medical writer, orreviewer). Users can create and manage projectsin PubSTRAT and assign tasks for projectcontributors to execute. Details of the scope andaudience for each journal or congress targeted inthe publication plan are hyperlinked inPubSTRAT.

PubSTRAT provides templates for generatingauthor invitations, author agreements, and elec -tronic checklists for meeting authorship require -ments, and it can capture digital signatures.

As such, PubSTRAT can be used to audit authorengagement and demonstrate compliance withGood Publication Practice guidelines andcorporate integrity agreements.

Publications can be viewed from a publi -cation management page (Figure 2). Furtherdetails for each publication, including the targetjournal, lead author, corresponding author,assigned medical writer, and active tasks, can beviewed from a project page. Managers can assignmedical writers to a project, which will trigger anautomated email to the writer. Workflows arecreated according to the timelines allocated inconfigurable project timeline templates, whichinclude document development, review, andapproval steps. Workflow subtasks may bedelegated to other authors or reviewers.Additionally, based on the timelines in theworkflows, automated reminder messages forauthors are triggered. The platform allows foronline document writing, simultaneous docu -ment review, and approval by internal andexternal authors. PubSTRAT includes suggestedtimelines by deliverable (e.g., abstract, poster,manuscript), which can be configured to meetthe client needs.

To help oversee the publication process, datavisualisation tools are available, includingperformance metrics (e.g., publications accepted,cancelled, in progress, pending finalisation, and

rejected) and budgeting tools (e.g. budget spentand remaining).

CITE CENTRALCITE CENTRAL is a centralised web-basedrepository for citation information and finaldocumentation for documents created inPubSTRAT. It creates automatic citations andconsolidates a product bibliography, and it can beused to disseminate publications to internal andexternal stakeholders.

Datavision®

Datavision (Envision) is a web-based softwareplatform that integrates a journal and congressdatabase of over 7,000 journals and 27,000congresses, a publication planning module, adocument management system, and a scientificcommunication platform.

Scientific communication platformThe scientific communication platform allowscompanies to load themes, key communicationpoints, and supporting statements into thesystem and then visualise how the publicationsalign with the publication plans. Optionalfeatures that may be purchased separately includean enterprise content management library thatallows publications to be captured, managed,archived, and distributed; finance and budgeting

Figure 2. Publication management page: PubSTRATIn the publication management page of PubSTRAT, tasks can be filtered by product, due date, or project. Projects can also be accessed by status onseparate tabs (“To Do”, “Planned”, and “Done”). By clicking the task, users can view this task in the overall timeline. By clicking the project name, userscan view project details shown in the project page. By clicking on the icon in the Actions column, users can delegate a task to a specific person.



Figure 3. Publication plan: DatavisionA. The Concepts tab of the publication plan shows a list of planned projects included in the publication plan. B. The Details tab, which provides the studies and other inputs upon which the publication plan is based. C. The Chart View tab shows a Gantt chart of projects included in the publication plan. D. The Gap Analysis view provides the planned publications by audience and tactic versus the plan’s inputs; for example, the input for the

congress EASD2020 shows that no abstracts are planned (indicated by the circle with an embedded zero). E. The Budget view shows the allocated budget vs. budget spent by project.



tools; automated healthcare provider debarmentchecks; and an enhanced scientific communi -cation platform.

Publication planning moduleIn the publication planning module, a wizard canbe used to design a publication plan that specifiestactics; audiences, journals, and congresses; andpotential differences between the plan and thecommunication objectives (Figure 3). Themodule provides metrics from the journal andcongress database, including the overallacceptance rate, the size and nature of theiraudience, and, for journals, the impact factor,Eigenfactor score, and types of articles published.A consolidated publication plan can be viewedfrom a summary list. (Figure 4).

The publication plan can be circulated,reviewed, and approved in Datavision.Datavision converts the details of the publicationplan into a PDF for review and approval.Reviewers will receive a notification that includesa link to the publication plan review. They cancomment on the publication plan usingembedded review software. Comments arestored in Datavision. Once it is approved, basedon the type of communication (e.g., abstract,poster, manu script, presentation) and submissiondeadline, the platform will generate a proposed

timeline that may be viewed from a projectmanagement page (Figure 5). Since Datavisionintegrates with clinical trial management systemsthat capture study timelines, Datavision can beused to highlight the required changes tomilestones in the publication plan if study dateschange.

Internal and external authors may be assignedto a project in Datavision. Author permissions,including the reports and dashboards they haveaccess to, are configurable. Electronic signatures(through DocuSign®) and electronic capture ofconflicts of interest and disclosures can becompleted in Datavision. To confirm authorshipeligibility, the platform also features an auto -mated debarment check (i.e., proposed authorshave been excluded, suspended, or otherwiseineligible to participate in Governmental healthcare programmes).

Managers can use the software to assign amedical writer, which will trigger an email to thewriter. Medical writers will interact withDatavision via a workbench view, which is aconsolidated list of assigned projects and currentand future tasks to perform. Medical writers canmanage author review and approval workflowsfrom this page. Automated reminders are trig -gered according to predefined but configurabletimelines. Supporting documents may be stored

for author access during review. By the third orfourth quarter of 2020, functionality for simu -ltaneous review by multiple reviewers will beenabled using doDOC (doDOC.com), a real-time co-authoring tool.

To provide managers with oversight of thestatus of the publication, reporting tools areavailable for document review metrics andbudget planning. An at-a-glance view of progressagainst the publication plan and projectmilestones is displayed on a Gantt chart. A dash -board view (Figure 6) provides high-level metricsby project, a document timeline, publi cation planmetrics, and a list of outstanding tasks. Reportscan be configured, saved as templates, andexported. Additional analytic features for furtherdata visualisation include integration with thedata analytics platform QlikView® and the abilityto export to other business analytics tools (e.g.,SAP BusinessObjects, Tableau, and Sisense).

To enable company-wide or role-specificdistribution, once publications are finalised, theycan be pushed from Datavision into a documentlibrary or another third-party document reposi -tory (e.g., Veeva Vault), which can be used tostore, manage, and distribute regulatory andclinical trial documentation. For each publi -cation, a count of citations is displayed. Theenterprise content management library can be

Figure 4. Publication Plan Concepts list: DatavisionThe Publication Plan Concepts list in Datavision includes a summary list of concepts (also known as tactics or strategicrecommendations) included within the publication plan. Users can click the hyperlinked project name to retrieve further details ofthe study included in each project, such as the first subject first visit, last subject last visit, publication type and audience, projecttimelines, and linked statements about the data to be relayed to appropriate external audiences.


used to develop and distribute a bibliography ofsuggested reading materials.

PubsHub™PubsHub (ICON) is web-based integratedpublication planning solution comprising a data -base of medical journals and scientific congresses( Journals & Congresses), software for publi -cation planning and management (PMSolution),

and a publication repository (KnowledgeManager). The software may be purchased as anintegrated solution or as separate modules. A subscription to PMSolution includes access toJournals & Congresses.

Journals & CongressesJournal & Congresses is a publication planningresearch engine that provides key data points for

over 4,600 journals, 3,500 congresses, and 4,000professional scientific associations, spanningmore than 100 medical and scientific therapeuticareas. Key metrics for journals and congressescan be compared (Figure 7). Content is updatedon an ongoing basis. Predatory journals andcongresses are flagged and excluded from thedatabase. Information for journals includes theimpact factor, circulation, readership, rejection


Figure 5. Project Management page: DatavisionIn the Project Management page of Datavision, the project manager can manage each publication. The left side of the page shows (A) documentdetails, including the target journal or congress, (B) the document version, (C) a link to supporting materials (e.g., tables, listings, literaturereferences) to be used in review and quality control, (D) the author list, and (E) a link to the study in the study database. On the right side ofthe page, (F) the project plan is presented by timeline, and (G) timeline step. Using the Actions dropdown menu (H), the project planmilestones can be updated and the document can be sent for review and approval.


Figure 6. Publication Manager dashboard: DatavisionIn the Publication Manager dashboard of Datavision, the left side of the dashboard provides (A) links to recent documents accessed, as well asoutstanding tasks, (B) a project status summary, and (C) pie charts showing projects by type and status. On the right side of the dashboard,(D) project managers can include alerts or other general information to be viewed by Datavision users and (E) display summary metrics forpublication status in a bar chart. In (F) a comparison of actual timelines (in dark green) and projected timelines (grey) is also presented.




rate, submission timeframes, restrictions on“encore” publications, and submission guidelines.For congresses, deadlines and the availability ofextensions are provided.

PMSolutionPMSolution is a software platform for projectmanagement and collaborative document reviewthat provides an audit trail for author involve -ment. It has two modes of operation fordocument review: a traditional workflow and“CoAuthorLive”.

In the traditional workflow, after initiating areview, reviewers receive an automated emailcontaining a link to access the document.Reviewers can sequentially access, edit, andupload a revised copy of the document.Reminder emails to reviewers are manuallytriggered. CoAuthorLive allows real-timesimultaneous review by multiple reviewers.

Key metrics (e.g., adherence to timelines byreviewers) are displayed on dashboards if meta -

data are added to the document. A forth comingupdate to the platform includes enhancedanalytic capabilities and data visualisation.

Medical writers and project managers canaccess and view the current status of projects viaa user-specific project dashboard (Figure 8).Security features are available to limit function -ality and access by user type. To facilitate projectcreation, a “copy project” feature enables repli -cation of project information, metadata, supp -orting documents, and team members. Lastly,PMSolution can track payments to authors.

PMSolution can be integrated with VeevaVault and can thereby be used for managementof document workflows. Once a document isapproved, it can be pushed into the VaultPromoMats document repository, which enablesautomated distribution to internal and externalstakeholders.

Knowledge ManagerKnowledge Manager is a document repository

for published copies of publications that can beintegrated with PMSolution. It can be used tosearch for publications and distribute them tointernal and external stakeholders. Supportinginformation for users, such as documentssupporting the rationale and key messages for thepublication, can be added. Content can besearched based on tagged metadata that aremanually entered.

ConclusionsMedical writers supporting scientific publi -cations can enhance their productivity by usinga comprehensive software solution that dovetailsall aspects of publication management, frominception of a publication plan to finaldissemination. Using a standardised softwaresolution can assure a consistent process, reducetime spent managing the tasks in executing apublication plan, and ensure compliance withindustry standards, transparency requirements,and standard operating procedures.

Figure 7. Journal Compare features (Journals & Congresses) PubsHubThe Journals and Congresses database of PubsHub provides a comparative view of journal metrics key to publication planning,including rejection rate, impact factor, and circulation. Timelines from submission to print publication are colour coded as green forsubmission to acceptance, purple for acceptance to online publication, and blue for acceptance to print publication.


While PubSTRAT, Datavision, and PubsHubinclude databases of journal and congress metricsto assist in publication planning, PubSTRAT andDatavision also include robust publicationplanning software packages with features thatallow stakeholders to design, modify, andapprove a publication plan. PubSTRAT andDatavision also include features to assist inexecuting the publication plan, includingtemplates for invitation emails to authors,automated author eligibility checks, assignmentof medical writing resources, and modifiabletimeline templates. Datavision’s integration withclinical trial management software allows for real-time updates in the publication managementplan when study timelines change. Finally,Datavision’s detailed dashboards allow managersto monitor the execution of the publication plan.

PubSTRAT, Datavision, and PubsHub supportdocument review and approval, and all supportsimultaneous collabor ative review rather thansequential review. They all include documentrepositories for published scientific communi -cations that integrate with the Veeva Vaultdocument management system. To furtherstreamline the publication management, future

iterations of publication management softwareshould include integration with journalsubmission platforms.

DisclaimersThe opinions expressed in this article are theauthor’s own and are not necessarily shared byher employer or EMWA.

Conflicts of interestThe author declares no conflicts of interest.

References1. Pharmaceutical Research and Manu fact ur -

ers of America; European Federation ofPharmaceutical Industries and Associations.Principles for Responsible Clinical TrialData Sharing. 2013 Jul 18 [cited 2019Nov 18]. Available from:https://www.efpia.eu/media/25666/principles-for-responsible-clinical-trial-data-sharing.pdf.

2. Recommendations for the Conduct,Reporting, Editing, and Publication ofScholarly Work in Medical Journals. 2019Dec [cited 2020 Mar 20]. Available from:

http://www.icmje.org/icmje-recommendations.pdf.

3. Battista WP, Wager E, Blazer L, et al. GoodPublication Practice for CommunicatingCompany-Sponsored Medical Research:GLP. Ann Intern Med. 2015; 163(6):461–4.

4. Sismondo S, Nicholson SH. Publicationplanning 101. J Pharm Pharm Sci.2009;12(3):273–9.

Author informationJackie Raskind, PharmD, is a principalmedical writer for KPS Life, LLC, workingremotely from Israel. She transitioned intomedical writing in 2014 after a 17-year careeras a clinical pharmacist in ambulatory,inpatient, and pharmacy benefit managedcare settings.


Figure 8. My Project dashboard page: PubsHubFrom the Primary Document tab in PubsHub, project or product managers can access all publications in development. Revisions topublications can be uploaded into PubsHub from this page. From the Supporting Documents tab, users can upload sources used inreview or quality control, and from the Document History tab, they can view versions and audit revisions.

https://www.efpia.eu/media/25666/principles-for-responsible-clinical-trial-data-sharing.pdf



http://www.icmje.org/icmje-recommendations.pdf

http://www.icmje.org/icmje-recommendations.pdf