• Menu
  • Skip to right header navigation
  • Skip to main content
  • Skip to primary sidebar

Before Header

Link Medical Research

CRO – Contract Research Organization

  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search
  • Home
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Experts
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
    • Other Services
  • Therapeutic areas
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Customer Testimonials
    • Our Memberships
  • News & Events
    • News
    • Events
    • Publications
    • Videos
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • LINK Team Testimonials
  • Search

Top Content

Expertise and technology
to optimize your
clinical trials
Home / Solutions / Clinical Development

Clinical Development

Essential CRO support for your clinical studies

For more than two decades, LINK Medical has been providing clinical development services to the pharmaceutical and medical device industries. Working closely with our clients, we overcome challenges and optimize solutions for the common goal of achieving superior trial outcomes. As part of the strategic partnership we offer, our dedicated teams and modern technology will optimize your clinical trials and accelerate the delivery of your innovative products to the physicians and patients who need them.

We offer end-to-end development solutions for your product or device, starting with early development advice, including regulatory advice meeting planning, development of market access strategies, marketing applications, and post-marketing activities – all from ONE source.
Our flexible solutions enable us to tailor our services to our client’s requirements. Whether you need insourcing of people or outsourcing of services, we carefully select the team that will have the most impact on your organization, freeing up your team to focus on what they do best. Our expert staff has significant experience coordinating early phase to phase IV trials, locally and internationally. Our medical team has a variety of expertise across different disease areas, including oncology and haematology, where the conduct of studies presents unique challenges. From planning and feasibility to the final study report, we ensure the highest quality outcomes and an exceptional customer experience.

Northern Europe Presence and Global Reach

LINK Medical is fully immersed in the markets in which we operate, offering full-service product development for the pharmaceutical and medical device industries, wherever our customers are located. Our integrated presence across Northern Europe enables you to access a rich local network of trial infrastructure as well as crucial knowledge of local regulatory landscapes.

We’ve built a network of trusted CRO partners worldwide to provide added flexibility and global coverage for your specific study requirements. Our partners are selected through our qualification process – evaluating quality, capabilities, delivery, technology, and more – to ensure they can provide a seamless extension to our services. Chosen partners are subject to regular re-evaluation to confirm continued to commitment to the values and high standards of LINK Medical.

Overview of services

Clinical Trial Phases
  • First-In-Man
  • Phase I (Including oncology and hematology)
  • Phase II
  • Phase III
  • Phase IV
  • Registries
  • Medical devices
  • Orphan indications
Clinical Trial Management
  • Project management
  • Study team set-up
  • Feasibility and site evaluation
  • Site identification
  • Operational set-up; e.g. plans, guidelines and manuals
  • Vendor selection and management
  • Site contract negotiations and management
  • Investigator and CRA meetings
Risk-Based Monitoring and site management

By implementing a Risk-Based Monitoring strategy we can work smarter and more effectively without compromising the quality of the clinical trial. By doing so we can focus our efforts on the relevant aspects of the trial and avoid any potential pitfalls. Our approach includes:

  • On-site and centralized monitoring
  • Targeted source data review and verification
  • Directed and flexible monitoring visits to sites, depending on need
  • Continuous review of trial data to identify potential errors and ensure high-quality data
Strategic Advice

Sometimes a development program hits a decision point and gets stuck. In such situations, external advice could be valuable. For new customers, we offer a free one to two-hour meeting with our Strategic Advice group which is led by our Medical Director and experienced people in Clinical Development, Medical Writing, Quality, Regulatory, Statistics, and Business Development. The free consultation is for a general Scientific advice session to chisel out initial areas to clarify, and help in formulating the questions that will help take your product further. Contact us to schedule your initial meeting free of charge here.

Start-up period
  • Target Product Profile development and training
  • Regulatory Project management
  • Regulatory Services
  • Scientific advice (briefing book, study design, CMC, pre-clinical)
  • Regulatory product strategy development
  • Core Document development (protocol, IB, IMPD etc.)
  • Clinical Trial Applications, including to biobanks
  • EU Legal Representation (for non-EU based clients)
  • EU GDPR Representation (for non-EU based clients)
Maintenance period
  • Site initiation and close out
  • Study subject recruitment planning, follow-up and reporting, contingency planning and actions
  • eTMF/TMF Management and quality control processes
  • Read World Evidence
  • Safety management and reporting
  • Medical monitoring through inhouse medical experts
  • Data Safety Monitoring Board formation
  • Training
  • Data management
  • Statistical involvement
  • Quality assurance/quality control
Closure and reporting period
  • Final data cleaning and database lock
  • Data sets
  • Statistical programming and analysis
  • Study report and submissions

Head of Department

Johanna Sundberg
Executive Vice President
Clinical Development
Johanna holds a PhD in toxicology and has over 20 years’ experience within research and the CRO industry, working extensively within phase I-II studies and associated project management. Johanna has been part of the Uppsala team since in September 2015 with different management roles including Director of Project management. Prior to that, she transferred from Quintiles where she held the position of Director, Clinical Project Management. Today Johanna is the VP of Clinical Operations where she supports Nordic teams as an international leader.

Contact via email

Primary Sidebar

  • Solutions
    • Early Clinical Development
    • Clinical Development
    • Post-Marketing
  • LINK Advantage – Full Service CRO
  • Market Access & RWE
  • Medical Device
  • Medical Experts
  • Medical Writing
  • PV – Pharmacovigilance Services
  • Clinical Operations
  • Clinical Project Management
  • Quality Assurance Services
  • Regulatory Affairs Services
    • Marketing Compliance
  • Biometrics CRO Services
  • Strategic Advice Group
  • Other Services

Site Footer

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

  • Home
  • Solutions
  • Therapeutic areas
  • About Us
  • News & Events
  • Contact
  • Careers
  • Search

© 2023 LINK Medical Research
Privacy Policy

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent. Read More
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_gat_gtag_UA_142237341_11 minuteSet by Google to distinguish users.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
nQ_cookieId1 yearAlbacross sets this cookie to help identify companies for better lead generation and more effective ad targeting.
nQ_userVisitId30 minutesNo description available.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
CookieDurationDescription
VISITOR_INFO1_LIVE5 months 27 daysA cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface.
YSCsessionYSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages.
yt-remote-connected-devicesneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
yt-remote-device-idneverYouTube sets this cookie to store the video preferences of the user using embedded YouTube video.
SAVE & ACCEPT
Powered by CookieYes Logo