Akela’s core services support our clients from draft protocol to first patient first visit and beyond to final report and ultimately to regulatory submission.
See below for a brief description of the principle services that Akela provides directly.
In addition we collaborate with a trusted network of high calibre industry professionals to provide full-service support including regulatory, audit, biometrics, medical writing, central laboratory and IMP management.
We will review your protocol for:
- feasibility at investigator site level
- compliance with all relevant guidelines
- logical consistency within the protocol
We have well established links with a select group of industry specialists for programme development, medical, regulatory and statistical input.
We have a database of experienced European investigators, including experts in the following indications:
We will compile a short list of investigators for your trial.
We will perform pre-study site visits internationally.
We will provide an independent recommendation of sites for inclusion.
We can help you manage your trials in the US, Canada, Europe, RSA and Australia either by staffing your project ourselves or assisting you to select the most appropriate vendor.
We will collect and verify all essential documents.
We will coordinate third-party vendors/suppliers.
We will organise the Trial Master File (TMF) and compilation of investigator site files, and site/study reference manual.
We will ensure the study is inspection ready at all times.
We will manage the investigator contracting process, Ethics Committee submissions and R&D approvals.
Finally, we will ensure the site is ready to recruit, including Study Site Coordinator training (if required).
We will provide solutions for ongoing Project Management and site monitoring (see separate descriptions).
We will tailor solutions for Investigator and Study Site Coordinator support according to the site’s experience. For example we can provide GCP training, if required.
We will prepare the site and train staff for audit or inspection.
Our experience of third-party vendors includes central labs, central ECG providers, couriers, translators, printers, meeting planners, bioanalytical and pre-clinical labs, drug distribution companies, data management/statistical companies, Auditors and small/medium size CROs if Akela feels they are better suited to help.
Firstly, we will create a shortlist of potential vendors from our market knowledge.
The next step is to manage the RFP process, evaluate proposals and verify references and relevant accreditation certificates to provide an independent recommendation.
Lastly, we advise that an audit be performed prior to contracting with a new vendor.
We will review and adapt your existing SOPs for compliance with relevant guidelines, local law, other applicable regulatory requirements and your SOP for writing SOPs.
If necessary we will recommend additional SOPs.
Our aims are to ensure consistency across all your SOPs and to truly reflect your working practices. This can only be achieved by collaboration with the individuals responsible for the task within your company. SOP writing is a team effort, which Akela is competent to lead.
We are experienced project managers, able to coordinate the efforts of multi-disciplinary teams regardless of geographical locations or organisational affiliation. We are accustomed to working as part of a ‘virtual CRO’ and often lead the team on behalf of our client. Proactivity, organisation and effective management of communication are key to the successful delivery of any project.
Overall clinical trial delivery requires the successful management of risk, not simply identifying the risk but managing it so that it does not materialise. Often the global development teams are virtual, through CROs or across many countries. This requires excellence in communication; never underestimate how little other people have heard or understood (including international teams) and recognise that there are not necessarily right or wrong answers. There is always uncertainty in clinical development but decisions have to be made based on the best overall body of evidence. A forensically trained mind is a tremendous asset to deliver on this.
We are experienced and thorough monitors, able to manage and motivate investigative sites, review data efficiently and with low query rates.
Our monitoring reports will provide all the information you need to demonstrate sponsor oversight. We are vigilant for issues and aim for our sites to be audit-ready at all times.
Our team is English-speaking; however, we have contacts globally should you require monitoring in the local language.
Our CRAs are always mindful that audits and inspections are possible at any time.
If you require clinical operations advice, perhaps to get your first drug into the clinic, but do not want the headcount and expense of a permanent employee, then Akela can help.
Akela can offer advice and support on an as needed basis for a variety of tasks. For example helping you to assemble the right team, select the most appropriate vendor or to take your protocol concept into a document fit for an Ethics Committee or Competent Authority.