Index 2017-06-07T11:19:32+00:00

Ophthalmology clinical and product life cycle management

• Bespoke Service
• Compliance
• Results Driven
• Proactive & Collaborative
• Integrity & Quality Assurance

Specialising in ophthalmology, the experienced, professional and friendly team at SJT Focus provide a broad range of bespoke services to small and emerging CRO’s, pharma and medical device companies in support of all areas of life-cycle management across Europe.

With a company ethos of providing a proactive, personal and flexible service, we work closely with our clients to deliver clinical trial management services including assistance with site selection & evaluation, protocol development, clinical trial submissions, CRAs (Clinical Research Associates) identification and monitoring activities, safety reporting, project management and medical writing activities to the highest standards.

As a client of SJT Focus, you will benefit from over 20 years of ophthalmology experience gained from working in the clinical, R&D and commercial arenas, with specialist expertise in the fields of glaucoma, IOLs, refractive laser and retina.

About

See what we are all about


SJT Focus was founded in 2013 by Dr Sally Tucker, an optometrist with a PhD in Ophthalmology, and provides assistance in the development, management, conduct and evaluation of clinical studies in ophthalmology. With extensive experience within the EU market, SJT Focus delivers a wide range of high-quality bespoke services including tailored clinical research solutions.

SJT Focus has experience in the development, management and oversight of investigatory and post-marketing clinical trials (including FDA PMA and pre-CE), in addition to market surveillance activities across Europe. Furthermore, the company is able to provide expert medical writing activities to assist with protocol development and the dissemination of results to the ophthalmology community. SJT Focus also has excellent, established relationships with key opinion leaders (KOLs) across the globe who it can work with to assist in the development of scientific protocols, identification of sites and delivery of results.

“Clients include global top 30 pharmaceutical companies.”

We are a results-driven business with proven success, delivering high-quality services for clients including global top 30 pharmaceutical organisations, as well as small and mid-sized CROs, pharma and medical device companies. The integrity of our research remains our highest priority and we bring a robust, proactive and quality-focussed approach to all the activities we conduct.

With more than 20 years’ experience working within the clinical, commercial and R&D fields of Ophthalmology and with first hand experience in the glaucoma (including MIGS), intraocular lens (IOLs), refractive laser and retina arenas, it means we have a unique understanding of the requirements for successful life-cycle management. We pride ourselves on providing a personal, collaborative service that meets your specific business needs whilst sustaining compliance and ensuring excellence is maintained.

Services

Take a closer look at what we can offer

As an SJT Focus client, we work in close collaboration with you to provide a high-quality, bespoke and proactive service that meets your individual business needs. SJT Focus has a dedicated and efficient infrastructure to manage all aspects of clinical trials and to assist with any other life-cycle management services such as medical writing and specific clinical trial related training.

Our wide-reaching network of industry contacts enables us to source the finest Clinical Research Associates and regulatory consultants across Europe in order to provide a comprehensive multifactorial service.

“Adherence to ICH GCP, EU and FDA regulatory and ethical requirements and ISO standards.”

You will benefit from our substantial experience in the management of multi-centre studies including FDA-compliant trials across Europe.

 SJT Focus can assist in all aspects of your project, including:

  • The development and writing of protocols
  • The submission of clinical trial applications to REC and Competent Authorities
  • CRF design and data management activities
  • Site selection
  • Site training and management (monitoring and project management)
  • ISF/TMF development and management
  • SOP development and quality management assurance
  • Writing of reports and manuscripts
  • Presentation of results
  • Safety reporting activities

We’re vastly experienced in the management of post-marketing trials and pre-registration FDA trials throughout Europe.

  • Protocol development
  • Site identification and qualification
  • Regulatory submissions
  • Clinical Research Associates and site training (product specific and GCP)
  • Monitoring and site management TMF maintenance
  • Project management and medical writing

“External ‘independent expert’ monitoring for university-sponsored ophthalmology studies.”

We have access to a wealth of quality monitors across Europe who provide tailored oversights to your clinical trial or investigation to ensure all regulatory and ethical requirements are being met and that the protocol is being adhered to.

Patient safety and research integrity are our top priorities, which is why we work closely with the monitors we source and the sites to make sure any issues are identified and resolved as quickly and efficiently as possible.

SJT Focus ensures that safety is effectively monitored throughout your clinical trial or clinical investigation.

We can aid in the expert and timely management of serious adverse events (SAEs) and adverse events (AEs) by helping with compiling the safety documentation required for the trial, including the safety section in the protocol, as well as assisting with the initial and follow-up SAE and AE reports. In collaboration with partners, we assisted with the review of adverse event coding.

SJT Focus will manage expedited reporting of any SAEs to the relevant authorities and regulatory bodies and aid with the writing of annual safety reports.

Our comprehensive medical writing service includes:

  • Abstracts and manuscript development
  • Manuscript review
  • Proofreading
  • Presentation development
  • Patient education literature

“Including CRF design trade journal articles, peer reviewed manuscripts and clinical investigation reports.”

We’re able to assist in the development of a diverse range of study-related documents, including:

  • Protocols
  • Investigator brochures
  • ICF and PIS development
  • CRFs development
  • Trade journal articles
  • Clinical investigation reports
  • Peer reviewed manuscripts
  • Presentations

Quality assurance
Our service is supported by a set of company SOPs and quality assurance processes as standard, including:

  • Creation and implementation of the study quality management plan to ensure oversight
  • Study documents quality checked to identify any issues
  • Assistance with the preparations needed for a regulatory inspection
  • Regular training
  • Tracking and reconciliation as standard

“Quality assurance processes as standard.”

Key opinion leader (KOL) interactions
SJT Focus has extensive experience in the identification and recruitment of respected KOLs and we will work together to ensure that engagement with them produces the greatest value for you.

Marketing
We are also able to provide specialist training to sales and marketing personnel and healthcare professionals.

Team
View our experience

Sally Tucker

Sally has extensive experience in all aspects of clinical trial management and has a specific interest in medical devices. She can assist with site selection and evaluation, monitoring and project management, medical writing and communications and KOL interaction as well as having extensive experience training personnel within the commercial and clinical environment.

Sally has a consummate understanding of the commercial needs of the ophthalmology industry and in a changing regulatory environment ensures compliance and excellence is at the forefront of the company’s ethos. As a diligent target and results-driven individual, Sally has a proven track record in the meeting of objectives and the successful management of obstacles to help clients avoid costly delays.

Sally has a wealth of experience in managing relationships and influencing individuals to focus on key objectives and, as an excellent communicator, ensures all stakeholders are aligned with the requirements and targets to ensure success. With a passion for knowledge and compliance through training, development through mentoring and clear visibility via communication, Sally provides excellence in all aspects of the projects she manages.

Donna Harrington

Donna Harrington has been working as a CTA with SJT Focus since May 2013. She is a graduate and has worked for over eight years in the clinical industry for organisations such as Genmab Ltd and Pharmacosmos A/S.

Katie Thompson

Katie Thompson joined SJT Focus in 2016 and brings with her over 10 years’ experience within the pharmaceutical and clinical trials industry. As a graduate in 2002, Katie spent the first few years of her career working in a lab environment as a research technician and lab manager at NPIMR, before moving to the Royal Veterinary College where she spent a further three years as a research technician and area safety supervisor in the Pharmacology Department. From there, Katie moved to become a research assistant at MRC Clinical Trials Unit followed by four years there as a data manager.

Amanda Costa

Amanda Costa deals with all administrative and organisational facets of the business. Her background in administration spans several years and includes working for an international training centre as registrar and also within a local school. Amanda started working for SJT Focus in February 2014 and continues to provide valued support to the team. Her experience is essential for the efficient running of the business.

Helen Buck

Helen Buck has a PhD in Neuroscience and an honours degree in Biological Sciences. She has over 22 years’ experience in the field of medical research, with special interest in clinical research, protocol management, medical writing, monitoring and SOP development.

Helen has experience of working with both large and small pharma and academic investigators and has worked within clinical trial departments of sponsor companies.

Other Partners

SJT Focus has established relationships with other clinical experts across the EU including CRAs, regulatory experts, project managers and medical writers to assist with meeting specific client requests.

Testimonials

Look at what others say about us

“It is rare to come across an individual such as Sally and I give her and her team my highest recommendation.”

“Over the last 3 years SJT Focus has assisted me during my review of subject safety events, serving as a liaison with the clinical sites regarding safety issues reported during Ivantis’ pivotal IDE study. Sally is very dedicated to the study and provides a very high quality of work. She has a positive attitude and a professional approach to her work. Her excellent communication and people skills, coupled with her strong background in ophthalmology, allow her to have a firm grasp on the clinical details and significant issues while managing her team effectively.”

Marina Ciccone, MS, Safety Reviewer for Ivantis Inc. - March 2017

“Sally is a true professional and I trust the quality of her work completely.”

“I have used Sally’s skills on various projects requiring editing, organisation, referencing and content creation over the last  2 years. She is an absolute pleasure to work with. Projects are always completed to time and to a high standard. I recommend her and her team very highly indeed.”

Allon Barsam, MB BS MA FRCOphth, Consultant Ophthalmic Surgeon, www.allonbarsam.com - February 2017

“Working with SJT Focus has given our company tremendous added value and I highly recommend every ophthalmic company planning a clinical trial in Europe to work with them.”

“Over the past year, Sally and her team at SJT Focus have been responsible for organising and preparing all the relevant material and activities for our upcoming multicentre clinical trial in EU, as part of the Horizon 2020 grant of €2.5M (in the field of glaucoma, ophthalmology). They have supported our company from the stage of preparing the Horizon 2020 proposal, designing and writing the protocol, ICF, CRF, planning the monitoring and follow up. Sally has attended all meetings with the clinical sites, and leads the process with professionalism, patience and hard work.”

Daria Lemann-Blumenthal, CEO - February 2017

“The contributions that SJT Focus has made to our study team and to executive management have been invaluable. We are a small company and could not have achieved the success of our trials without the total commitment demonstrated by Sally Tucker and her team.”

“SJT Focus has been a critical component of our clinical study programs for an innovative ophthalmic implant in Europe since 2011. Over the past 6 years, we have undertaken 4 major randomized controlled trials, one of which includes an IDE pivotal trial. SJT Focus has managed all aspects of these trials to ensure GCP compliance with ISO 14155 and local regulations including Ethics Committee approvals and reporting, clinical study monitoring, adverse event reporting and additional statutory compliance. Sally Tucker, the Owner and Director of SJT Focus served a vital role in ensuring the clinical sites are well prepared and in conformance to all aspects of the study protocols. She provides comprehensive communications both to the clinical sites and to the study managers at the home office in the United States.”

Helene Spencer, VP, Regulatory Affairs / Quality Assurance / Clinical Affairs Ivantis, Inc. - February 2017

“The ability to effectively utilize European clinical centers accelerated study completion by more than half a year.”

“We have partnered with SJT Focus Limited and Dr Tucker for over several years on the premarket clinical evaluation of an implantable ophthalmic device in the UK/EU under a FDA Investigational Device Exemption. Dr Tucker effectively managed approval, recruitment and follow up stages of the study in multiple European countries in compliance with a complex protocol and with 21 CFR part 812 and MDD regulations. SJT Focus Limited integrated easily into US based clinical operations and worked effectively toward meeting Corporate objectives.”

Brett Trauthen, Chief Scientific Officer, Ivantis Inc. - June 2015

“Our collaborative work with SJT Focus Limited has benefited our projects beyond expectation. SJT Focus Limited was a tremendous support to us in providing invaluable expertise through her deeply founded experience. SJT Focus Limited  always keeps deadlines no matter how tightly scheduled and completes their tasks very reliably. They are not afraid to think out of the box to help find alternatives when necessary. This provides inestimable worth for ensuring a successful project outcome.”

Michael Mrochen, CEO IROC Science to Innovation www.irocscience.com - 2014

“Sally is a well-educated vision science professional with good all round skills. She has demonstrated expertise in effective management of multiple clinical studies and meeting tight timelines and business objectives. While Sally is capable of working independently to deliver results, she can integrate well into a team environment. Sally has good communication skills and a wealth of experience in interactions with regulatory, field clinical, marketing, and physician personnel on technical and operational objectives. Her work ethic, sincerity, and pleasant demeanor has earned the respect of her colleagues and will be a valuable asset to any organization.”

Manoj Venkiteshwar, Global Medical Affairs Brand Leader - IOL at Alcon Laboratories, Inc. - April 2013

“Sally provided an extremely effective link between operations and R&D which resulted in the achievement of positive outcomes for medical device clinical studies that she was responsible for. Great interpersonal skills combined with thoroughness and persistence enabled her to be successful in this and her previous marketing role. Sally is highly regarded and has excellent credibility within the ophthalmic community.”

Niven Smith, Healthcare Executive - May 2012

“I had the opportunity to experience Dr Tucker’s performance as the lead on many medical affairs’ projects that required Clinical Trial Management of Phase IV studies, KOL development and Training. The measure of professionalism, passion and skill sets managing an extraordinary number of projects reflect the highest level of integrity, capabilities and time management. Dr Tucker has an uncanny ability to accomplish herculean tasks that result in great outcomes with limited resources and time. She brings excellence to her work and has my highest recommendation.”

Robert Cortes, MD FAAFP - CMO of Advanced LifeCycle Management, LLC

“Sally has experience in all area of a product’s life cycle. From very effective project management of clinical trials to impactful direct-to-consumer campaigns to enhance sales revenues. Her knowledge and experience in ophthalmology are excellent. She has a very personable manner and has great communication skills. These allow her to interact very effectively with all levels within an organization and to deliver high standards and results in a timely manner. Sally became an effective project manager within our organization seamlessly and delivered improvements within a very short time frame increasing clinical trial enrollment performance. I would not hesitate to recommend Sally at any time.”

Tim Kelleher, Managing Director EMEA Ivantis Inc. - April 2012
Contact
Get in touch and see what we can do for you

Dr Sally Tucker
MCOptom, PhD, Dip Tp (AS), Dip Tp (SP), PGDip
Managing Director, SJT Focus Limited

 

m: +44 (0)7976 543104
t: +44 (0)1582 460292

Contact Form

Ophthalmology clinical and product life cycle management

Dr Sally Tucker
MCOptom, PhD, Dip Tp (AS), Dip Tp (SP), PGDip