Clinical Development Plan
The ultimate goal of a robustly designed Clinical Development Plan (CDP) is to define the critical path for the clinical
development program including the required Phase I-Phase IV clinical studies, patient support programmes, decision points and resources required to obtain regulatory approval with an optimal label (prescribing information) and which should ultimately ensure commercial success.
The CDP is a ‘living’ document that is progressively adapted and refined as each clinical study phase is completed. ACROSS has a wealth of expertise to design, develop and ultimately deliver a robust CDP tailored specifically for your investigational product / device. Your path to success!
Regulatory Affairs
Regulatory affairs ensures that investigational products and medical devices are developed in accordance with legislative
requirements in the markets in which they are to ultimately be launched. As the global legislative environment is very complex with both country level (e.g. U.S. FDA, National Competent Authorities, etc.) and above country level (e.g. European Union, Eurasian Union, etc.) regulations in place, our professional ACROSS ‘Regulatory Affairs’ team members will guide you and your product(s) step by step through the complexities of the required regulatory processes.
The knowledge of country level and above country level regulatory peculiarities is also a key to a robust Clinical Development Program as well as for choice of clinical trial design (including important post-marketing activities to maintain the life-cycle of the product). Ensuring legal compliance!
Feasibility
ACROSS Global provides a robust and structured approach to the conduct of clinical trial feasibility. Utilizing a variety of sources including but not limited to, partner proprietary databases, subscription databases and importantly first-hand experience / knowledge with potential clinical investigational sites, ACROSS will help evaluate the conduct of a prospective clinical trial / program in a particular geography(ies) with the ultimate goal of determining not only the best sites for a specific clinical trial(s) but also to ensure complete alignment and satisfaction with your overall project timelines, objectives and budget.
Selecting the right sites from the outset!
Project Management
From ‘Alpha-to-Omega’, from the beginning to the end of a study, our well trained, professional, and dedicated ACROSS Global Project Managers (GPMs) apply their wealth of experience and knowledge to your study.
Utilizing simple and effective agile management tools and processes and with a solid pro-active and solution driven conviction, our GPMs will keep you up-to-date with well-designed, timely study progress reports as well as guide your study safely and effectively to its final conclusion. Providing project oversight at its best!
Monitoring
Our ACROSS monitors will provide oversight of your study(ies) in alignment with ICH-GCP-E6 (R2) and the laws established by relevant regulatory authorities. In addition, all monitors are well trained according to SOPs, the sponsor’s protocol, as well as the therapy area of focus.
Following carefully written and approved Monitoring Plans, our monitors provide the primary interface between the sponsor and the Principal Investigator and his/her site staff, thus establishing solid relationships with our carefully selected sites. From site selection, initiation, interim-monitoring and close-out visits our monitors can conduct both on-site as well as remote monitoring. We have fully embraced Risk Based Monitoring and additionally offer Centralized Monitoring as and when required. Your critical link to the site!
Data Management – Biostatistics
ACROSS offers you a number of different options for your bio-statistical and data management needs which can be tailored to your specific budget.
Data Management is fully integrated into the broader clinical trial processes providing for excellent data quality to all our clients. With robust SOPs, Statistical Analysis Plans / Data Management Plans and using tried, tested and validated Electronic Data Capture (EDC) systems we are able to work seamlessly to combine your data from the myriad of sources encountered in clinical trials (e.g. e-CRF, Laboratory data, e-PRO and other third party sources). Your data is in safe hands!
Medical Writing
At ACROSS we see medical writing as both a science and an art. It requires a comprehensive understanding of medical science as well as a thorough knowledge of specific content requirements for various types of medical documents in addition to keeping up-to-date with the ever evolving regulatory environment.
Medical writers are a core component of our clinical research teams and each has the necessary in-depth knowledge of specific therapy areas. Our medical writers can manage the full array of clinical trial related documents including but not limited to clinical study protocol, investigational brochure, informed consent documents, clinical study reports and publications. We look forward to writing for you!
Quality Assurance
In accordance with ICH-GCP E6 (E2), Quality Assurance is defined as “All those planned and systematic actions that are
established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in
compliance with Good Clinical Practice (GCP) and the applicable regulatory requirements”.
Within ACROSS we have a team of auditors with broad array of language skills, based in a variety of strategic locations across the globe that provide localized knowledge with an impressive geographical reach for our clients. This multi-talented and experienced team of auditors provides a comprehensive range of services including but not limited to:
a) Assisting clients with preparations for audits and regulatory inspections (e.g. U.S. FDA, EMA, as well as from other national
authorities).
b) Broad range of audit types including but not limited to:
a. On-site audits
b. Trial Master File audits
c. Monitoring project audits
d. Process audits
e. Vendor audits
f. Pharmacovigilance audits
g. Country Medical Department audits
h. Internal audits
c) Set-up and maintenance of company Quality Management Systems
d) Preparation of ISO Certification
e) Outsourcing of QA
f) Quality Risk Management
g) Standard Operating Procedure (SOP) writing
h) Ad-hoc QA services
i) Consultancy