TranScrip Clinical Development and Operations

TranScrip’s expertise extends across the range of activities required to design and successfully implement clinical programmes for regulatory approval and product differentiation, from interaction with thought leaders and regulators, development of protocols through medical monitoring to preparation of study reports and summaries.

Expertise
Experience

TranScrip Clinical Development and Operations Experts

TranScrip’s Clinical Development and Operations team has worked with many clients in the design and successful implementation and clinical programmes for regulatory approval and product differentiation. TranScrip interacts with thought leaders and regulators to guide programme design and is frequently involved in the development of protocols, medical monitoring and preparation of study reports and summaries. For small and start-up companies, TranScrip has established their trial oversight processes to ensure GCP compliance.

Carol Burley
Head of Clinical Development and Operations

Carol has been with TranScrip since 2009. She is Head of Clinical Development and Operations and has expertise in the management of various clinical development projects, including regulatory submissions.

As a member of TranScrip’s Quality Management Committee, Carol is involved in all aspects of GCP compliance within TranScrip. In addition, having worked for major pharmaceutical companies as well as in a CRO, she is well-placed to understand clinical development and operations from the viewpoint of a service provider as well as a customer. Carol has worked in the pharma industry for over 30 years and in clinical development for 25 years. She was on the Board of Directors of the Institute of Clinical Research during the period 2011-2013.

Judi Proctor
Head of Medical Writing, Graphics and Translation

Judi is Head of TranScrip’s medical writing and document auditing, and has been with TranScrip for 5 years. She has over 20 years medical writing experience working with a number of mid to large CROs.

Judi has a broad range of expertise in medical writing for both drugs and devices, across a wide range of therapeutic and development functional areas, particularly oncology, infectious diseases, respiratory and internal medicine.

Judi has experience in writing, auditing and project managing a wide range of documents including protocols, CSRs, IB, ICFs, PILs, PSURs, RMPs and DDRMPs, regulatory submission documents, manuscripts posters and abstracts. Judi leads TranScrip's graphics and translation and has experience of training industry personnel in medical writing and a variety of other pharmaceutical topics, including ICH, GCP, study specific training and communication skills.

Judi has in the past been the membership officer for the European Medical Writer’s Association (EMWA) and deputy editor and copy editor for the Write Stuff (the EMWA Journal). She holds a post graduate certificate in education, a Postgraduate Diploma in Science and Society and an MSc in Science.

Case Study

This case study outlines the wide and important role which TranScrip has played in Clinical Development and Operations.​

Challenge

A small biotech company moved its product into clinical development and needed to complete a phase II study on limited resources before receiving further funding.

Solution

TranScrip Partners provided clinical, regulatory, drug safety, and operational support along with internal staff training.

Result

Phase II study completed on time and within budget. Operational systems successfully inspected by MHRA.

TranScrip Partners provide Clinical Development and Operations support in various therapy areas to include:

Portfolio/product review and positioning

Planning of clinical trial programmes from early development to registration

Design and preparation of clinical trial protocols

Medical monitoring of clinical trials with 24/7 coverage

Medical writing, including clinical study reports, investigator brochures, etc.

Interactions with key opinion leaders, preparation of advisory boards, etc.

Expertise in many therapeutic areas for NCEs and biological

Complete virtual support for small biotech operations