STRATEGIC PLANNING

Early stage emerging technology companies have very specific product development needs based on not only their technology but the culture inherent to such companies.  Arkios understands this; members of our company have experienced it first-hand.  At Arkios, we can help identify and meet your specific needs. This may start with a Strategic Regulatory Plan that describes the roadmap to successful FDA approval, includes direct FDA input, and may be critical in securing investment capital.  As Arkios assists you with pre-IND work, we will continue the relationship with the FDA, directed at making sure you fulfill all requirements for a successful IND.  We will also identify and manage pre-IND pharm and tox vendors.  We can help you decide which specific efficacy claims should be made.  Arkios will plan your early clinical development program, and provides full clinical project management services, thus giving you continuity of service from a group that is intimately familiar with your specific technology. 

CLINICAL OPERATIONS AND REGULATORY AFFAIRS

Our Team works hard to assure that your product meets FDA standards for GCPs and GMPs.  Arkios provides product development advice and regulatory support based on an understanding of CBER/CDER/CDRH policies.  We walk our clients through Strategic Planning, pre-IND tasks, and into the writing and submission of an IND/IDE.  Our qualified staff manages all IND and IDE submissions.  Once in clinical trial phase we handle study initiations and secure all regulatory documents needed to begin the trial. We assist sites with IRB submissions in order to expedite the approval process and train them in GCPs to maintain regulatory compliance. Our staff is trained in human subject protection as well as the Code of Federal Regulations and ICH guidelines.  We are also well-versed in international regulations, and are prepared to assist with global product development as necessary.  Our project management and monitoring staff members are highly-trained and certified.  We also provide excellence in medical writing, protocol development, and preparation of other documents.

DATA MANAGEMENT AND BIOSTATISTICS

FDA approval is as dependent on the quality of data as it is on results.  Arkios delivers quality, clean data through a formal process according to industry-accepted SOPs. Data management activities begin prior to study initiation with other departmental team members to define logic checks and balances to promote database quality. Our SOPs are designed to address each Sponsor’s project specifications and accommodate Good Clinical Practices in a definitive manner.

Data Management is involved at the start of a project with CRF development, data collection guidelines, database specifications, and logic checks design. Through early involvement of Data Managers, the process of data cleaning is more efficient since "clean data" is defined from the beginning of the project. These guidelines are outlined in our Data Validation Plan.  The plan provides a comprehensive overview of the cleaning of the entered data.  Arkios also provides thoroughly detailed plans for audits, lab collection and medical coding. Coding is done with MedDRA, WHOART, COSTART, WHODrug or dictionaries developed by the Sponsor.  Our systems are SAS driven and we are able to provide sponsors with SAS output and databases that are the industry standard. 

Tracking systems are in place to document and trace the receipt and flow of each CRF page and data query through the data entry and cleaning process. Clinical Data Managers continue involvement in the evaluation, analysis, and report review to provide insight and enhance deliverable quality.

Databases for paper-based systems are designed using SAS at Arkios.  Our experienced programmers use the flexible database structure to design, build, and validate databases for any paper-based or fax-based clinical trial. Our process includes CRF emulated entry screens, independent double entry, computer generated audit trail, and dedicated modules to track CRFs, queries, patient status, and protocol violations.

Arkios offers a password protected portal site.  Utilization of this tool will ease communication among sponsors, monitors, and other key personnel regardless of time or location. The site may include (but not be restricted to) metrics, timelines, study specific discussions and actual clinical data.   This portal was created with the intention to improve project management by  enhanced communications and allowing for earlier identification of possible issues.

PHASE I OUTPATIENT VACCINE DEVELOPMENT

We work with a local clinical research center that facilitates our ability to manage and perform Phase I Outpatient Vaccine Safety and Immunogenicity trials.